Too Much of a Good Thing?
|
|
- Camilla Powers
- 6 years ago
- Views:
Transcription
1 Regulatory s Role in Reviewing External Corporate Communications Too Much of a Good Thing? By John Driscoll Every regulatory professional is a reviewer. One could even say that the majority of our work is reviewing the writing of others. Since our reviews are not based upon a specific legal requirement, and since they necessarily add significant time (and complication) to a document s approval process, how do companies in this heavily regulated industry decide which documents regulatory affairs (RA) should review? The most obvious criterion is whether or not the document will be part of a future regulatory submission. Only a few documents that are ordinarily part of regulatory submissions are not normally reviewed by RA prior to finalization (e.g., case report forms (CRFs)). The business rationale for tying RA review closely to submissions is that regulatory professionals, through their expertise, are presumed to have the best understanding of the regulatory authority s perspective. RA should, 20 March 2009
2 therefore, be able to provide valuable input that will lead to the desired outcome of the FDA review. Most companies would not want to put something in front of an FDA reviewer without prior review by a regulatory professional. In the case of submission documents, the perceived benefits of RA review are high. However, for documents that are not intended to be part of a formal regulatory submission, RA review is much less common. For example, many internal company documents that provide critical support for heavily regulated activities (e.g., pharmacovigilance or Quality Assurance) are not ordinarily reviewed by RA, even though they are subject to FDA review upon inspection. In these cases, the potential benefits of RA review are outweighed by the relatively low risk of FDA scrutiny. A more controversial area is RA review of external corporate communications. As most of Regulatory Focus 21
3 More people will see a television commercial for a drug than will ever likely read its product label. these communications are not subject to FDA review ahead of release, and because enforcement is relatively rare, FDA authority over them is viewed as much less well-defined. As a result, RA s involvement in these documents can vary significantly between companies. This article focuses on the major areas of external corporate communications within our industry and discusses some of the benefits of having RA review these materials. Drug Labeling & Promotional Materials Approved product labeling plays an essential role in the communication of a drug s efficacy and safety information to physicians and patients. Given its potential to impact the public health negatively, a drug label is also the most heavily regulated document within our industry. Since nearly all changes to a drug label require FDA approval (or in a few cases, just notification) prior to implementation, RA is at the center of all labeling development, review and approval in most organizations, including responsibility for writing a drug product labeling standard operating procedure (SOP) to formalize the process. Yet while drug product labeling is the most regulated document in our industry, it is the drug s associated promotional materials that are the most prominent. More people will see a television commercial for a drug than will ever likely read its product label. Moreover, the increasing attention paid by the public to the promotional activities of our industry only intensifies the regulatory exposure. Although corporate marketing departments are responsible for creating draft promotional materials, in most companies RA will be very closely involved in their review and approval (including the internal materials used to train sales representatives). In many mediumsized and large companies, regulatory professionals are employed full-time to focus on promotionrelated concerns. Unlike drug product labeling, promotional materials for drugs do not need to be approved by FDA prior to dissemination in most cases. However, they do need to be submitted to FDA at the time of first use. This submission requirement means that most companies give RA general oversight of the internal review and approval process of promotional materials (i.e., to ensure these pieces are not used prior to FDA submission). In most companies, compliance is achieved through a formal SOP written by RA. If FDA enforcement occurs in the form of a Notice of Violation (NOV) letter (inspections for promotional materials are rare), RA will almost certainly take the lead in responding to FDA and oversee any internal corrective action to ensure that all agency concerns have been adequately addressed. Press Releases Press releases are developed by a corporate communications department (usually investor relations or public relations) to announce company news to the public. FDA has historically interpreted corporate press releases as promotional communications and has objected when it believes a press release is false or misleading per the promotion regulations. Even a press release on a product in development can be subject to FDA enforcement if it is believed to constitute promotion of an unapproved drug. Because press releases are intermittent, most companies have a review and approval process that is much less formal than those for product labeling or promotional materials. Some within our industry have argued that for a publicly traded company, the public disclosure requirements of the Securities and Exchange Commission (SEC) trump FDA regulations, especially considering the typical audience for press releases is the media and investors, not the physicians, patients or managed care organizations that comprise the typical audience for drug promotion. Nonetheless, in practice, RA is usually part of the review of any press release that includes product-specific information. Certainly, some kinds of press releases (such as quarterly earnings statements) do not need RA review, but at a minimum, given the potential for FDA action, any press release that mentions an investigational or approved drug product should undergo RA review. In reviewing something like a press release, however, an important distinction between promotion and other external corporate communications needs to be maintained. Information that would be off limits if it occurred in a clearly promotional context is not necessarily forbidden to be mentioned in a press release. For example, while any mention of the positive results of a clinical trial in an off-label indication would, if uttered by a sales representative to a doctor, likely be considered violative promotion by FDA, a press release disclosing the results of a recently completed study may not be, provided the press release made no conclusions or claims about the safety or efficacy of a drug in the unapproved indication. The transformation of clinical data into product claims will always make the issuance of a press release a promotional activity in the view of FDA. 22 March 2009
4 Scientific Publications & Medical Science liaisons (MSls) As active members of the scientific community, most pharmaceutical companies will maintain internal publications and medical science liaisons (MSL) groups within medical affairs to communicate new scientific information about their products. These communications range from materials presented at scientific meetings (e.g., research posters) to major articles published in peer-reviewed scientific journals. Although the goal of these groups is the peer-to-peer dissemination of scientific information, FDA has previously targeted certain oral statements at scientific meetings and the use of article reprints as violative of the promotion regulations. Given the history of these actions by FDA, it might appear to be common sense for RA to be involved in the review of any product-related external communications issued or used by these groups. However, this is not always the case. Many within the industry (including many regulatory professionals) believe that including RA as a reviewer of scientific communications disrupts the freedom of a purely peer-to-peer interaction and inappropriately presumes the communication is subject to the regulatory requirements of drug promotion. While this is a valid concern, it is also important for a company to consider the extent to which the marketing department is involved in developing the content of these scientific communications. If there is significant marketing influence (i.e., review), a company should consider including RA review as a counterbalance. Medical Information ( Responses to unsolicited Requests for Information ) Most companies maintain a Medical Information group within medical affairs to disseminate information to physicians if requested. The dissemination of off-label information is allowed by FDA through this channel as long as the information is provided in response to an unsolicited request. In December 2008, FDA s Division of Drug Marketing, Advertising and Communications (DDMAC) sent an untitled NOV letter to AstraZeneca regarding oral statements about an off-label use made by a sales representative to a physician. The FDA letter notes that in the 26 March 2009
5 course of the conversation, the physician challenged the sales representative s off-label claims and requested additional information to support them. Shortly afterward, AstraZeneca sent the physician a Medical Information letter detailing the available clinical study data on the off-label use. Since the letter was not a response to an unsolicited request for off-label information, DDMAC considered the company s dissemination of the letter to be a violative promotional activity. DDMAC even went so far as to include a copy of the Medical Information letter as an attachment in its letter to AstraZeneca. Of note is that FDA would have had no objection to AstraZeneca s Medical Information letter if it had been in response to a genuinely unsolicited request, but also that FDA will consider these sorts of communications to be promotion if they are not distributed appropriately. In many companies, RA does not review Medical Information letters. Again, there is a valid concern that including RA in the review of such materials fosters an appearance of promotional activity. While it is unlikely (though not unheard of) for marketing to be involved in the development or dissemination of Medical Information letters, at a minimum it is critical for RA to ensure appropriate processes exist for the dissemination of these materials. Conclusion In reviewing external corporate communications, RA needs to be sensitive to the different requirements of each area. The strict promotion regulations do not apply in all cases. A key consideration in whether or not regulatory should be reviewing an external corporate communication is whether marketing is part of the development, review or approval. Any external communication influenced by marketing may be considered promotional by FDA and should have appropriate regulatory review to balance any product-related messages. F Author John Driscoll is a Regulatory Affairs professional in the New Jersey area. He can be reached at jrdrisc@post.harvard.edu.
FDA COMMUNICATIONS. Oversight in a. DIGITAL era A WHITE PAPER
FDA COMMUNICATIONS Oversight in a DIGITAL era 2008-2013 A WHITE PAPER Mark S. Senak, J.D. Author, Eye on FDA Senior Vice President & Partner Fleishman-Hillard 04 / 2013 Table of Contents Summary Overview...
More informationRules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders
Rules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders Daniel Snyder, PhD Medical Director, Neurology North America Medical Affairs Ipsen Biopharmaceuticals, Inc.
More informationFDA Update on Oversight of Prescription Drug Promotion
FDA Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration November 7, 2018 Topics Medical Product Communications That
More informationRECRUITING OF AND ADVERTISING FOR SUBJECTS
1. POLICY Steering Committee approved 9/19/11 The informed consent process begins when a potential human research subject first learns of a study, which is usually accomplished through recruitment efforts.
More informationOPDP Update on Oversight of Prescription Drug Promotion
OPDP Update on Oversight of Prescription Drug Promotion Thomas Abrams Director Office of Prescription Drug Promotion Food and Drug Administration November 3, 2014 1 Topics Policy and Guidance Development
More informationOff-Label Promotion: Risks, Controls and Assessment
7 th th Annual National Pharmaceutical Congress November 9, 2006 Off-Label Promotion: Risks, Controls and Assessment John T. Bentivoglio Co-Leader FDA/Healthcare Group jbentivoglio@kslaw.com 202.626.5591
More informationDTC Promotion and Guidance: OPDP Update. Michael Sauers Team Leader, DTC1 FDA/CDER/OPDP DTC National Conference April 12, 2012
DTC Promotion and Guidance: OPDP Update Michael Sauers Team Leader, DTC1 FDA/CDER/OPDP DTC National Conference April 12, 2012 DTC Promotion and Guidance Guidance Update Submission Totals DTC Enforcement
More informationBest Practices to Ensure Compliance with Scientific Exchange. Dennis Raglin, Partner Life Sciences Practice Group SEDGWICK LLP San Francisco 2015
Best Practices to Ensure Compliance with Scientific Exchange Dennis Raglin, Partner Life Sciences Practice Group SEDGWICK LLP San Francisco 2015 Scientific Exchange Unsolicited requests Unapproved use
More informationAmerican Academy of Orthopaedic Surgeons 2010 Annual Meeting
American Academy of Orthopaedic Surgeons 2010 Annual Meeting Off-Label Device Use: When Clinical Need Outpaces Regulatory Approval The Legal Parameters of Off-Label Use March 10, 2010 Kathleen McDermott
More informationOff-Label Use Congress and FDA must balance: The need to regulate manufacturer promotion of off-label use of devices; and The need for and availabilit
Off-Label Use Versus Clinical Trial Use of Devices: FDA Regulatory Issues Neil F. O Flaherty Principal Olsson Frank Weeda Terman Bode Matz PC Off-Label Use Uses that do not appear in a device s FDA-approved
More informationEnforcement and Policy Update from Office of Prescription Drug Promotion
Enforcement and Policy Update from Office of Prescription Drug Promotion Thomas Abrams, R.Ph., M.B.A. Director Office of Prescription Drug Promotion Food and Drug Administration November 2, 2011 1 Topics
More informationAugust 25, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
August 25, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA Docket No. FDA-2014-D-0758-0001 Draft Guidance for Industry on Distributing
More informationAgency and Internal Labeling
Agency and Internal Labeling Audits Joseph McMillian, MA Heartland Compliance Services LLC Internal Labeling Audits The views and opinions expressed in the following PowerPoint slides are those of the
More informationWhile the recognition
Designing the Perfect Change Control System Change control systems today are expected to be designed in a way that provides a system to not only document and approve changes, but also to anticipate change
More informationAmendment to the Medical Council s Statement on advertising in relation to the use of testimonials
8 March 2016 Amendment to the Medical Council s Statement on advertising in relation to the use of testimonials The Medical Council of New Zealand (the Council) is proposing to amend part of its Statement
More informationWASHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW WASHINGTON, D.C (202) September 13, 2006
WASHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW WASHINGTON, D.C. 20036 (202) 588-0302 By Facsimile [301-796-9877] and First-Class Mail September 13, 2006 Thomas Abrams, RPh, MBA Director Division
More informationTHE FDA REGULATORY AND COMPLIANCE SYMPOSIUM
THE FDA REGULATORY AND COMPLIANCE SYMPOSIUM Managing Risks From Pipeline to Patient Presented by: Steven A. Johnson, Esq., Vice President and Assistant General Counsel, Allergan, Irvine, CA Keith M. Korenchuk,
More informationPromotion & Advertising of Combination Products: Key Postmarket Considerations
Combination Products Regulation, Policy, & Best Practices It s A Whole New Ballgame Are You All In? June 8, 2017 Promotion & Advertising of Combination Products: Key Postmarket Considerations Moderated
More informationPublic Attestation Criteria for Consumer Advertising Preclearance Agencies Recommended by Health Canada
December 8, 2006 Health Canada s Recommended Public Attestation Criteria for Advertising Preclearance Agencies in Canada who provide review and preclearance services of nonprescription drugs and natural
More informationOREGON HEALTH AUTHORITY DRUG USE REVIEW/PHARMACY AND THERAPEUTICS COMMITTEE. OPERATING PROCEDURES Updated: March 2018
OREGON HEALTH AUTHORITY DRUG USE REVIEW/PHARMACY AND THERAPEUTICS COMMITTEE OPERATING PROCEDURES Updated: March 2018 MISSION: To encourage safe, effective, and innovative drug policies that promote high
More informationPost NDA/ANDA Approval Commitments
Coalition for PET Drug Approval Post NDA/ANDA Approval Commitments SNMMI Annual Meeting - June 9, 2014 Michael Nazerias Director Regulatory Affairs PETNET Solutions, Inc. (a Siemens Company) Session Objectives
More informationMay 2, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers
More informationWARNING LETTER. Below is the indication and summary of the most serious and most common risks associated with the use of Ampyra. 1
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Ron Cohen, M.D. President & Chief Executive Officer 420 Saw Mill River Road Ardsley, NY
More informationUniversity of California, Irvine Human Research Protections Standard Operating Policies and Procedures
University of California, Irvine Human Research Protections Standard Operating Policies and Procedures Policy Number: 41 Title: Investigational Drugs, Agents, and Biologics Date of Last of Revision: 07/28/2006;
More informationROLE OF THE RESEARCH COORDINATOR Investigational New Drug Application-Sponsor Responsibilities 21CFR Part , subpart D
Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Investigational
More information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More information'Safe Harbor' For Preapproval Information Exchange To Get Legislative Push
Other Publications: Scrip Medtech Insight In Vivo Rose Sheet This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers,
More informationPromotion of an Investigational New Drug; False or Misleading Promotion
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Beth D. Gudeman Chief Executive Officer 670 Perimeter Drive Lexington,
More informationBiopharmaceutical Company Communications with Health Care Stakeholders RESULTS OF SURVEYS WITH PAYERS AND PROVIDERS
Biopharmaceutical Company Communications with Health Care Stakeholders RESULTS OF SURVEYS WITH PAYERS AND PROVIDERS DECEMBER 2017 Executive Summary As biomedical research continues to push into new frontiers
More informationRe: Docket No. FDA 2005-D-0339: Draft Guidance on Drug Safety Information FDA's Communication to the Public
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org May 8, 2012 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville,
More information11.0 FDA-Regulated Research Research Involving Investigational Drugs and Biologics
11.0 FDA-Regulated Research The IRB evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationRecruitment of Research Participants
IOWA STATE UNIVERSITY Institutional Review Board Recruitment of Research Participants Recruitment of research participants takes many forms that involve presenting potential participants with information
More informationMerck s Alignment with PhRMA DTC Principles (Updated January 30, 2009)
Merck s Alignment with PhRMA DTC Principles (Updated January 30, 2009) Effective January 1, 2006, the Pharmaceutical Research Manufacturer s Association (PhRMA) implemented the PhRMA Guiding Principles
More informationCOVERAGE ELIGIBILITY OF SERVICES ASSOCIATED WITH A CLINICAL TRIAL
Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its
More informationMedical Affairs Not a Sunshine Day Analyzing the Impact of the Sunshine Act on Medical Affairs: Challenges for 2014 and Beyond
Medical Affairs Not a Sunshine Day Analyzing the Impact of the Sunshine Act on Medical Affairs: Challenges for 2014 and Beyond Jodi Smith, PhD and Peg Crowley Nowick, PhD, MBA Medical Affairs Not a Sunshine
More informationThe Distinction Between Advertising and Other Activities
POLICY Issued: January 12, 1996 Health Products and Food Branch Administrative Update: August 2005 The Distinction Between Advertising and Other Activities Issue Health Canada recognizes the importance
More informationCommercial Speech and the First Amendment
Commercial Speech and the First Amendment Commercial speech (advertising products, etc.) does enjoy certain free speech rights, although it is not protected to the same extent as political speech. Initially,
More informationEffective Auditing of PV Interfaces
Outline Effective Auditing of PV Interfaces SQA Meeting March 29, 2017 Larry Thomas, RQAP-GLP, CQA Bayer Pharmaceuticals Whippany, NJ Audit Process Planning/Preparation, Execution and Reporting Functions
More informationDrug Safety and FDA Revitalization Legislation
Drug Safety and FDA Revitalization Legislation Dan Kracov August 23, 2007 FDA Regulatory and Compliance Symposium House and Senate FDA Revitalization Bills Senate: S. 1082, Food and Drug Administration
More informationLDT Review: The New York Experience
LDT Review: The New York Experience APHL Meeting, Indianapolis, May 21, 2015 Erasmus Schneider, Wadsworth Center, NYS DOH erasmus.schneider@health.ny.gov May 21, 2015 May 21, 2015 2 As the New York State
More informationAdvertising and Marketing Genetic Tests New Pathways or Old Roads?
Advertising and Marketing Genetic Tests New Pathways or Old Roads? Kathleen M. Sanzo, Morgan Lewis FDLI Advertising & Promotion Conference Wednesday, September 28, 2016 Context for Use of Genetic Tests
More informationTo document the review procedures for a submission regarding compassionate/treatment use of investigational drugs, biologics and devices.
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD COMPASSIONATE/TREATMENT USE OF MEDICAL DRUGS, BIOLOGICS AND DEVICES I. PURPOSE To document the review procedures for a submission
More informationSeptember 16, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
September 16, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2014-D-0447: Draft Guidance for Industry on Internet
More informationFDA Issues Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion
FDA Issues Draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion How to Convey the Good, Bad and Ugly By Alan G. Minsk, Jennifer S. Blakely and Meredith
More informationAuthorship and Algorithms: Assessing Authorship at Lilly. Jeffrey W. Clemens, Ph.D. Eli Lilly and Company
Authorship and Algorithms: Assessing Authorship at Lilly Jeffrey W. Clemens, Ph.D. Eli Lilly and Company 1 Disclosure I am an employee and stockholder of Eli Lilly and Company. Eli Lilly and Company has
More informationAmgen GLOBAL CORPORATE COMPLIANCE POLICY
1. Scope Applicable to all Amgen Inc. and subsidiary or affiliated company staff members, consultants, contract workers, secondees and temporary staff worldwide ( Covered Persons ). Consultants, contract
More informationPage2 Docket No. FDA-2013-N-0745 November 20, 2013
Via Electronic Submission Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Food and Drug Administration Safety and Innovation Act
More informationDRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Document issued on: July 14, 2011
Draft Guidance for Industry and Food and Drug Administration Staff In Vitro Companion Diagnostic Devices DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued
More informationGUIDANCE ABOUT CLAUSE 3
GUIDANCE ABOUT CLAUSE 3 On occasion pharmaceutical companies will have a legitimate need to tell health professionals and others about unlicensed medicines or indications. This guidance will help companies
More informationHow to Implement Effective Controls on a Company-Wide Basis. John B. Moriarty, Jr. Senior Vice-President Law Elan Pharmaceuticals, Inc.
How to Implement Effective Controls on a Company-Wide Basis John B. Moriarty, Jr. Senior Vice-President Law Elan Pharmaceuticals, Inc. How to Implement Effective Controls on a Company- Wide Basis Agenda:
More informationUsing Benefit Risk in Making Post Market Decisions. Adam E Saltman MD PhD Medical Officer, FDA CDRH Office of Compliance AFDO 2018
Using Benefit Risk in Making Post Market Decisions Adam E Saltman MD PhD Medical Officer, FDA CDRH Office of Compliance AFDO 2018 Objectives Understand why FDA is interested in the benefit-risk approach
More informationWASHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW WASHINGTON, D.C (202)
WASHINGTON LEGAL FOUNDATION 2009 MASSACHUSETTS AVENUE, NW WASHINGTON, D.C. 20036 (202) 588-0302 By Facsimile [301-796-9877] and First-Class Mail November 15, 2006 Thomas Abrams, RPh, MBA Director Division
More information1201 Maryland Avenue SW, Suite 900, Washington, DC ,
1201 Maryland Avenue SW, Suite 900, Washington, DC 20024 202-962-9200, www.bio.org January 11, 2011 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane, Rm. 1061 Rockville,
More informationInternational Transfers of Personal Data at sanofi-aventis R & D
International Transfers of Personal Data at sanofi-aventis R & D Pierre-Yves Lastic, PhD Senior Director, Standards Management & Data Privacy Sanofi-aventis R&D CONFERENCE ON INTERNATIONAL TRANSFERS OF
More informationIND Development Process Published on ResearchGo UCLA (
IND Development Process IND Development Overview The Pre-IND Process The IND Study Protocol Preparing the Initial IND Submission Filing the IND Maintaining the IND IND Templates, Education and Useful Links
More informationKeywords: fi eld-medical, medical science liaisons, metrics, return on investment, consensus
Measuring performance of field-medical programmes: Medical science liaison metrics consensus Jane Chin Date Received (in revised form): 11th June, 2007 Jane Chin is President of Medical Science Liaison
More informationBest practice for communicating R&D progress to investors and the public
Best practice for communicating R&D progress to investors and the public Developed in collaboration with CONSILIUM strategic communica ons What is the purpose of this guide? Ensuring investors and the
More informationComments of the Interactive Advertising Bureau on Internet and Social Media Promotion of FDA-Regulated Medical Products. Docket No.
Comments of the Interactive Advertising Bureau on Internet and Social Media Promotion of FDA-Regulated Medical Products I. Introduction Docket No. FDA-2009-N-0441 February 26, 2010 The Interactive Advertising
More informationStatements on the Regulation of Laboratory Developed Tests
Statements on the Regulation of Laboratory Developed Tests Current Regulatory Gaps and Perspectives on Oversight of LDTs American Cancer Society Cancer Action Network says Molecular tests, in particular,
More informationThe Case for Streamlined Complaints Management in Medical Devices. Consulting
The Case for Streamlined Complaints Management in Medical Devices Consulting Increasing challenges in the evolving medical industry will require a more integrated complaints management approach The medical
More informationFDA s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs) By Roz Sweeney, Ph.D., Nerac Analyst
FDA s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs) By Roz Sweeney, Ph.D., Nerac Analyst Introduction The FDA recently issued updated draft guidance for proposed regulatory changes affecting
More informationFDA Requirements for Clinical Investigations of Medical Devices: A Review for European Manufacturers
FDA Requirements for Clinical Investigations of Medical Devices: A Review for European Manufacturers Autumn Dawn Ediger, 1, * Birgit Limbach 2 and Dieter Dannhorn 3 1 Regulatory Affairs, Clinical QM and
More informationYour complimentary Clinica Medtech Intelligence content
Your complimentary Clinica Medtech Intelligence content Clinica provides you with up to the minute coverage and opinion on company, product, market and regulatory developments as well as market size, growth
More informationStem Cell Uses and FDA Regulation
Stem cells have been called everything from cure-alls to miracle treatments. But don t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware
More informationGuidance for Industry
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationGuidance for Industry
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationMedical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Guidance for Industry
Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers Guidance for Industry Elizabeth Pepinsky Health Science Policy Analyst Office of Prescription Drug
More informationUnder this license, you are approved to manufacture aflibercept drug substance intermediate, drug substance, and formulated bulk at
DEPARTMENT OF HEALTH AND HUMAN SERVICES Silver Spring MD 20993 Our STN: BL 125387/0 BLA APPROVAL November 18, 2011 Regeneron Pharmaceuticals, Inc. Attention: Laura Pologe, Ph.D. Associate Director, Regulatory
More informationInvestigational New Drug Development Steps for CRCs
Investigational New Drug Development Steps for CRCs Natalie Nardone, PhD Program Manager, Department of Medicine CRC Instructor, Office of Clinical Research Contact: natalie.nardone@ucsf.edu Learning Objectives
More informationPhRMA GUIDING PRINCIPLES DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES
PhRMA GUIDING PRINCIPLES DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES P hrma GUIDING PRINCIPLES DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES PREAMBLE Given the progress
More information2014 Was a Good Year for FDA & Pharma
Jan 2015 Vol. 14, No. 1 Pharma Marketing Network www.pharmamarketingnews.com 2014 Was a Good Year for FDA & Pharma Banging Year for Drug Approvals, Wimpy Year for Enforcement Actions Author: John Mack
More informationRe: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products Content and Format
September 7, 2018 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling
More informationPerspective: Convergence of CLIA and FDA Requirements A Rational Shift in the Regulatory Paradigm
Perspective: Convergence of CLIA and FDA Requirements A Rational Shift in the Regulatory Paradigm Planning for Efficiencies of Data, Resources, and Timelines A PRECISION BRIEF Introduction As precision
More informationTown of Lincoln COMPREHENSIVE PLANNING PUBLIC PARTICIPATION PLAN. Prepared by the Town of Lincoln Plan Commission
COMPREHENSIVE PLANNING Prepared by the Town of Lincoln Plan Commission Adopted by the Town of Lincoln Town Board November 2007 With assistance from: TOWN OF LINCOLN COMPREHENSIVE PLANNING PURPOSE Public
More informationMedical Products between
Proactive Communications about Medical Products between Manufacturers and Payors FDLI Advertising & Promotion Conference September 27, 2017 David J. Bloch Principal Legal Counsel, Corporate Legal Regulatory
More informationHuman Research Protection Program Guidance for Human Research Determination
Human Research Protection Program Guidance for Human Research Determination I.1.A The sole purpose of the Institutional Review Board (IRB), as defined in federal statutes, is the protection of human subjects
More informationThe role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
in partnership with The role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) CTRad Clinical Trials Workshop 14/10/2014 What is
More informationApril 13, Background
Pfizer Inc 235 East 42nd Street New York, NY 10017-5755 Tel 212 733 4210 Fax 646 383 9249 Email: marc.wilenzick@pfizer.com April 13, 2009 http://www.regulations.gov Christine Ireland Committee management
More informationOrthopaedic Innovation: Bench, Bedside, Bank
Stephen P Makk, MD, MBA A Seth Greenwald, D-Phil (Oxon) Biomedical Engineering Committee American Academy of Orthopaedic Surgeons 1 1 The Patent Process www.uspto.gov 2 2 Patent: A government grant allowing
More informationAppropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products
Date: April 23, 2012 Appropriate Control Strategies Eliminate the Need for Redundant Testing of Pharmaceutical Products Key Messages Importation quality control testing for pharmaceutical, biological/biotechnology
More informationHuman Research Protection Program Policy
Page 1 of 5 REVIEW OF INVESTIGATIONAL NEW DRUG (IND)/INVESTIGATIONAL DEVICE EXEMPTION (IDE) RESEARCH IN HUMAN SUBJECTS RESEARCH POLICY It is the policy of the University of Cincinnati that studies involving
More informationFourth Annual Pharmaceutical Regulatory and Compliance Congress
Fourth Annual Pharmaceutical Regulatory and Compliance Congress Preconference I A Compliance Primer for the Pharmaceutical Sector Michael P. Swiatocha November 12, 2003 Agenda for Preconference I Introduction
More informationOptimizing the Impact of the Medical Affairs Function
Optimizing the Impact of the Medical Affairs Function Tim Dietlin, Vice President, Medical Affairs Practice Keith Morris, Practice Executive, Medical Affairs Practice Introduction The Medical Affairs function
More informationBipartisan Policy Center, Top Medical Innovation Priorities
Bipartisan Policy Center, Top Medical Priorities FDA: Advancing Medical is a Bipartisan Policy Center initiative led by former Senator Bill Frist, MD, former Congressman Bart Gordon, and BPC Health Initiative
More informationWARNING LETTER. Dave Stack President and CEO Pacira Pharmaceuticals, Inc. 5 Sylvan Way Parsippany NJ 07054
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 TRANSMITTED BY FACSIMILE Dave Stack President and CEO 5 Sylvan Way Parsippany NJ 07054 RE:
More informationOff-Label DTC Advertising
September 2016 Vol. 15, No. 4 Pharma Marketing Network www.pharmamarketingnews.com Off-Label DTC Advertising Will FDA Be Forced to Allow It? Author: John Mack Published by: Pharma Marketing Network PMN1504-01
More informationCase 1:17-cv JMF Document 113 Filed 08/30/18 Page 1 of 5 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK
Case 1:17-cv-03960-JMF Document 113 Filed 08/30/18 Page 1 of 5 UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK CHARLES SEIFE, v. Plaintiff, FOOD AND DRUG ADMINISTRATION and DEPARTMENT
More informationSocial Media and the In-House Counsel
Bylined Article Social Media and the In-House Counsel Mathew dos Santos and Lori Leskin A version of this article originally appeared in Pharmaceutical Executive on June 1, 2014. Social media plays an
More informationMinimizing Risky Business: A New Model to Gain Control Over Unmanaged Promotional Claims
Minimizing Risky Business: A New Model to Gain Control Over Unmanaged Promotional Claims Introduction Current approaches to managing promotional claims have failed to keep pace with the realities faced
More informationGlobal Clinical Trials in Korea
Global Clinical Trials in Korea In-Sook Park Department of Drug Evaluation Korea Food & Drug Administration Contents Regulatory changes relevant to Clinical Trials in Korea Current Status of Clinical Trials
More informationSWOG
SWOG http://swog.org Page 1 of 5 pages Original Release Date: May 2007 Departments Affected: All Revision Date: May 2014 POLICY ON ADVERTISING FOR SUBJECT RECRUITMENT AND TRIAL PROMOTION When Federal human
More information~_Awl (99' ~.,..,~., ~.. FEDERAL EXPRES S. Cahill, Dear Mr.
~_Awl (99' ~.,..,~., ~.. ~J+ DEPARTMENI.OF HEALTH & HUMAN SERVICES Public Health Serv ice FEDERAL EXPRES S WARNING LETTER Food and Drug Administratio n Center for Devices and 1 ~ ~yy Radiological ~ Health
More informationShifting Pharma Sales Models. Text for a pull out can go heretext for a pull out can go heretext for a pull out can go
Text for a pull out can go heretext for a pull out can go heretext for a pull out can go Text for a pull out can go here Text for a pull out can go here Shifting Pharma Sales Models to Focus on Providing
More informationRisk Management Plan Guidance
1 / 17 Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety Ⅰ, Pharmaceuticals and Medical Devices Agency This English version is intended to be
More informationActing Deputy Commissioner for Operations, U.S. Food and Drug Administration
Available on FDA website at: http://www.fda.gov/newsevents/testimony/ucm113266.htm Pediatric Clinical Trials for Anti-depressant Drug Products Statement of Janet Woodcock, M.D. Acting Deputy Commissioner
More information11.0 FDA-Regulated Research
11.0 FDA-Regulated Research The HSC evaluates the safety or efficacy of all drugs and devices used in research. Studies involving unapproved or investigational drugs or devices will be reviewed to ensure
More informationAUDIT COMMITTEE CHARTER DATED AS OF AUGUST 5, 2010
AUDIT COMMITTEE CHARTER DATED AS OF AUGUST 5, 2010 Committee Membership: The Audit Committee of the Board of Directors (the Board ) of KBS Strategic Opportunity REIT, Inc. (the Company ) shall be comprised
More informationTopics. Safety First Initiative. Drug Safety Communications DRUG SAFETY INITIATIVES AT THE FOOD AND DRUG ADMINISTRATION
DRUG SAFETY INITIATIVES AT THE FOOD AND DRUG ADMINISTRATION Presentation to the FDA/Industry Conference sponsored by the School of Pharmacy at Temple University May 6, 2008 Topics Safety First initiative
More informationNontraditional Venues: Are They Promotional?
FDLI Advertising and Promotion for Medical Products Conference October 16-17, 2018 Nontraditional Venues: Are They Promotional? Heather Banuelos Counsel King & Spalding LLP Kai Peters Partner Gordon &
More informationCompassionate Use Navigator Information for Physicians
Compassionate Use Navigator Information for Physicians Contact: Elena Gerasimov, Program Director, Elena@kidsvcancer.org. As a physician, you must have wished there would be more treatment options for
More information