CGMP and Postmarketing Safety Reporting Requirements for Combination Products
|
|
- Curtis Boyd
- 6 years ago
- Views:
Transcription
1 CGMP and Postmarketing Safety Reporting Requirements for Combination Products GMP by the Sea August 29, 2017 Mark D. Kramer Regulatory Strategies, Inc. 1
2 Definition of a Combination Product A combination of a drug, device and/or biological product: Single entity physically/chemically combined prefilled syringe cells on scaffold drug-coated device drug-biologic conjugate) Co-packages of devices, drugs and/or biologics Cross labeled products 2
3 The CGMP Regulation 21 CFR 4 Effective July 22,
4 Legal Theory: Combination = Sum of Parts Drugs, devices and biologics retain their regulatory identities in the combination product Both drug and device requirements apply to a drugdevice combination product The CGMP and postmarket safety reporting requirements that apply to each of the constituent parts continue to apply in the combination product 4
5 Underlying CGMP Requirements For medical devices: 21 CFR 820 (Quality System Regulation) For drugs: 21 CFR 210/211 (Drug CGMPs) For biological products: Either 21 CFR 210/211 or 21 CFR CFR (as applicable) 21 CFR 1271 (for HCT/Ps) 5
6 Two Options to Demonstrate Compliance Fully implement both sets of CGMP regulations (211 AND 820) OR Streamlined approach : Fully comply with a primary set of requirements (211 OR 820) AND Comply with specific requirements of the other set of regulations that are unique to that type of article and would be lost if not required 21 CFR Part 4 Final Rule Available at: 6
7 Streamlined Approach Requirements Unique to Drug GMPs (21 CFR 211) Common Elements Requirements Unique to Device GMPs (21 CFR 820) 7
8 Choice of Base CGMP Operating System At manufacturer s discretion Most facilities will already operate under one approach and it is easier to incorporate the add-on provisions New facilities may have no pre-existing approach and can select the option best suited for the product as a whole Both approaches are permissible and neither is considered preferable by FDA This flexibility only applies to combination products If the facility also manufacturers drugs or devices, they must be fully compliant with 211 and/or 820 8
9 210/211 Base Device Add-on s Management responsibility Design controls Purchasing controls Corrective and preventive action Installation Servicing Design controls will likely be the main gap for most drug/biologic sponsors the above requirements apply to the device constituent part and the combination product as a whole 9
10 820 Base Drug Add-on s Testing and approval or rejection of components, drug product containers, and closures Calculation of yield Tamper-evident packaging (for OTC drug products) Expiration dating Testing and release for distribution Stability testing Special testing requirements Reserve samples All can be gaps for device companies, to varying degrees 10
11 Eligibility to Apply Streamlined Approach Sites that manufacture more than one type of constituent part of a combination product: Different types of constituent parts have arrived at or manufacture of different constituent parts is proceeding at a facility Single entity and co-packaged combination products only Cross labeled products are separately manufactured and don t require special treatment for CGMPs, HOWEVER 2017 FDA guidance allows streamlined approach if both constituent parts manufactured at same facility 11
12 Real-World Activities Demonstrate compliance with 21 CFR 4 in marketing applications for new combination products Expect PAI s to address these requirements Routine inspections.perhaps less so (?) Also ensure compliance for legacy combination products Remediation may be necessary to address design controls Component acceptance, yield, stability and retention for device companies A product is a combination product and subject to the CGMP rule if it meets the definition even if FDA has not identified the product as a combination product 12
13 The PMSR Regulation 21 CFR 4 Effective January 19,
14 Underlying Postmarketing Safety Reporting Reqts. For medical devices: 21 CFR 803 (Medical Device Reporting) 21 CFR 806 (Corrections & Removals Reporting) For drugs: 21 CFR 314 (Drug Adverse Experience Reporting ) 21 CFR 314 (Field Alert Reporting) For biological products: 21 CFR 600 (Biological Product Adverse Experience Reporting) 21 CFR (Biological Product Deviation Reporting) 21 CFR 606 (CGMPs for Blood/Blood Components) 14
15 Overall Approach Common Elements: Drug/Biologic Alert, Field Alert and BPDR Reporting Reporting of Death and Serious Injuries Device Malfunction, 5-Day and Corrections/Removals Reporting 15
16 Applicability of New Requirements Final rule applies only to combination product and constituent part applicants (application holders) Constituent part applicant: reporting requirements apply only to its constituent part Combination product applicant: reporting requirements apply to its combination product as a whole 16
17 Overall Reporting Scheme Dictated by Application Type If the combination product or device constituent part received marketing authorization under a device application, comply with 21 CFR 803 and 806 If the combination product or drug constituent part received marketing authorization under an NDA or ANDA, comply with 21 CFR 314 If the combination product or biological product constituent part received marketing authorization under a BLA, comply with 21 CFR 600 and
18 Additional Requirements for Combo Applicants Devices If the combination product was approved under BLA, NDA or ANDA and includes a device constituent part, also submit: 5-day reports (21 CFR 803.3/803.53) Malfunction reports (21 CFR ) Correction and removal reports (21 CFR ) 18
19 Additional Requirements for Combo Applicants - Drugs If the combination product was approved under a BLA or device application and includes a drug constituent part, also submit: Field alert reports (21 CFR ) 15-day reports (21 CFR ) however the regulation permits reporting within 30 calendar days instead of 15 calendar days if the product was approved/cleared under a device application 19
20 Additional Requirements for Combo Applicants - Biologics If the combination product was approved under NDA, ANDA or a device application and includes a biological product constituent part, also submit: Biological product deviation reports ( / ) 15-day reports (21 CFR ) (with the same 30 calendar day allowance stated above if the product was approved/cleared under a device application) 20
21 Periodic Safety Reporting Requirements for Combination Product Applicants NDA, ANDA or BLA holders with combination products including a device constituent part must include a summary and analysis of their malfunction and 5-day reports in their periodic safety reports, in addition to the standard content of these periodic reports Device application holders may be required by FDA to submit additional postmarketing safety events (such as periodic reports) and will be notified by Agency in writing if applicable 21
22 Information Sharing (Constituent Part Applicants) Upon receipt of information involving a death or serious injury (as defined in the MDR regulation) or adverse experience (as defined in the NDA or BLA regulations) associated with the combination product, the applicant: Must provide the information to the other constituent part applicant(s) within 5 calendar days of its receipt of the information Maintain records of what was shared, the date received, the date provided, and the name and contact information of the person to whom the information was provided Preamble: Party sharing information is not required to analyze, investigate or take any action beyond forwarding to the other party nor are they required to share follow-up information 22
23 How and Where to Submit Reports Constituent part applicants: follow reporting regulation applicable to the type of application (e.g., device application follow MDR instructions) Combination product applicants: Individual case study reports (15-day, malfunction, death/ serious injury, 5-day reports) reported as per application type assures review by lead Center Correction/removal and NDA field alert reports District Office as usual BPDRs CDER or CBER 23
24 Summary: Where and When Reports are Submitted Type of Report Where Submitted Timeframe (Days) 5-Day Report Lead Center 5 days Malfunction Report Lead Center 30 days Correction/ Removal Report District Office 10 days 15-Day Alert Report Lead Center 15 days (30 days if approved/cleared under device application) NDA Field Alert Report District Office 3 days Biological Product Deviation Report CDER or CBER 45 days Death or Serious Injury CDRH (only applies if approved under device application) 30 days 24
25 Compliance Timeframes Currently in effect as of January 19, 2017: Existing reporting requirements per application type July 19, 2018 (18 months after the effective date) for the new requirements: Additional reporting provisions specific to the additional constituent part Device events in drug/biologic periodic safety reports Information sharing for constituent part applicants Recordkeeping requirements 25
26 Real World Activities Applies to legacy combination products meeting the definition as well as newly approved products, whether specifically identified as combination products or not Ensure PMSR procedures are developed and implemented and reflective of regulation by compliance date Don t need to wait until July 2018 to implement the new requirements; use narrative sections to describe events until forms are changed Additional FDA guidance expected to address several practical aspects of rule, such as MedWatch form completion, assignment of codes, etc. 26
27 Questions? Mark D. Kramer Regulatory Strategies, Inc
Combination Products Workshop: CGMP and PMSR Requirements. GMP by the Sea August 28, Mark D. Kramer Regulatory Strategies, Inc.
Combination Products Workshop: CGMP and PMSR Requirements GMP by the Sea August 28, 2017 Mark D. Kramer Regulatory Strategies, Inc. 1 Definition of a Combination Product A combination of a drug, device
More informationPostmarketing Safety Reporting and cgmp Requirements for Combination Products. Katlin McKelvie Backfield November 2, 2017
Postmarketing Safety Reporting and cgmp Requirements for Combination Products Katlin McKelvie Backfield www.backfieldpllc.com November 2, 2017 Background: What is a Combination Product? Combination product:
More informationThe Impacts of FDA Combination Product Rulings on Medical Devices
The Impacts of FDA Combination Product Rulings on Medical Devices Khaudeja Bano Arlington, VA - June 14 th 2017 15 th Product Complaint Congress for Life Sciences Disclaimer Speaker s personal opinion
More informationISPE Annual Meeting 29 October 1 November 2017 San Diego, CA
Post Marketing Safety Reporting (PMSR) Challenges and Successful Practices for Combination Products Objective Session Goals Summary of the final rule Interpretation for combination products approved as
More informationCOMBINATION PRODUCTS. Karyn M. Campbell, Director Investigations Branch Philadelphia District Office Food and Drug Administration
COMBINATION PRODUCTS Karyn M. Campbell, Director Investigations Branch Philadelphia District Office Food and Drug Administration Regulations 78 Federal Register (78 FR) 4307, published 1/22/13, effective
More informationGuidance for Industry and FDA:
1227 25th St., NW Washington, DC 20037-1156 Guidance for Industry and FDA: Application of cgmp Regulations to Combination Products: Frequently Asked Questions PROPOSED GUIDANCE January 15, 2007 This guidance
More informationCBI s 15 th Annual Product Complaints Congress for Life Sciences
CBI s 15 th Annual Product Complaints Congress for Life Sciences June 14, 2017 Steven Niedelman Lead Quality Systems & Compliance Consultant King & Spalding LLP 1700 Pennsylvania Ave., NW Washington, DC
More informationIndustry Perspective of US Combination Product Rule: Postmarket Safety Reporting Challenges and Proposed Solutions
Industry Perspective of US Combination Product Rule: Postmarket Safety Reporting Challenges and Proposed Solutions June 2017 By: Khaudeja Bano, Chair of the Combination Products Coalition (CPC) Postmarket
More informationPlamena Entcheva-Dimitrov, PhD, RAC On-line Course.
Plamena Entcheva-Dimitrov, PhD, RAC On-line Course 1 The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright
More informationThe Rise of the Medical Device/Pharmaceutical Product combination and how it affects traditional Pharmacovigilance
German Pharmacovigilance Day 02. June 2015 The Rise of the Medical Device/Pharmaceutical Product combination and how it affects traditional Pharmacovigilance Abstract Abstract Medical Devices and Pharmaceutical
More informationTeleconference Course Materials You may duplicate this for each person attending the conference.
TC140515 Teleconference Course Materials You may duplicate this for each person attending the conference. FDA s Former Director of the Office of Combination Products Looks at the Effects of the New GMP
More informationCombination Products: A 40 Year Regulatory Evolution
The right people. The right solution. The first time. Combination Products: A 40 Year Regulatory Evolution Technological advances in healthcare products and the delivery of those products will continue
More information3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.
POLICY #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional
More information3.1. Overall Principal Investigator (PI), who holds the IND and is the Sponsor.
SOP #: RCO-100 Page: 1 of 11 1. POLICY STATEMENT: An Overall Principal Investigator (PI) who holds an Investigational New Drug Application (IND) and who is the Sponsor of the research has additional responsibilities
More informationISPE Annual Meeting 29 October 1 November 2017 San Diego, CA. Combination Product Updates, Initiatives, and Case Studies. Steven B. Hertz, P.E.
Combination Product Updates, Initiatives, and Case Studies Steven B. Hertz, P.E. Consumer Safety Officer, FDA/CDER/OPQ Agenda 1: CP Overview 2: CDER Updates : CP Application Info : Case Studies 5: Summary
More informationCombination products Updates Final FDA Guidance
Compliance Seminars Combination products Updates Final FDA Guidance Presented by Anna Lundén Webinar, March 8, 2017 Intentionally blank Compliance Seminars Our international course program for GMP professionals
More informationCombination Products Part 4 Compliance and Implementation at multi-site Network
Combination Products Part 4 Compliance and Implementation at multi-site Network Vijay Damodaran Eli Lilly & Company September 27, 2017 Contents Key cgmp requirements for combination products How to perform
More informationRe: Docket No. FDA-2008-N-0424: Postmarketing Safety Reporting for Combination Products
701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org June 14, 2018 Division of Dockets Management (HFA-305) Food and Drug Administration
More informationCombination Products: QS & Design Controls Requirements
Combination Products: QS & Design Controls Requirements M. Isabel Tejero, MD PhD Office of Compliance CDRH, FDA Isabel.Tejero@fda.hhs.gov Presentation Goals Introduction to combination product CGMP requirements
More informationPrevent Quality System Deficiencies by Conducting Effective Internal Audits. Whitepaper
Prevent Quality System Deficiencies by Conducting Effective Internal Audits Whitepaper An internal audit system is one of the most effective ways to monitor, analyze, control, and improve quality management
More informationTable of Contents Adverse Event Reporting SOPs for Medical Devices
Page 2 of 122 Table of Contents Adverse Event Reporting SOPs for Medical Devices Previous Teleconferences About SOPs... 7 Dr. Sharlin's Credentials... 8 Outline Of This Presentation... 9 CDRH Requirements
More informationCDER 2016 Actions and 2017 Priorities. Richard Moscicki Deputy Center Director for Science Operations, CDER, FDA
CDER 2016 Actions and 2017 Priorities Richard Moscicki Deputy Center Director for Science Operations, CDER, FDA Disclosure My comments today are mine and do not necessarily represent the views of the US
More informationCOMBINATION PRODUCTS A RECENT FDA PERSPECTIVE. Sugato De
COMBINATION PRODUCTS A RECENT FDA PERSPECTIVE Sugato De Principal Consultant Integrated Product Development PAREXEL Consulting June 29, 2018 GLOBAL BIO CONFERENCE 2018 2018 PAREXEL INTERNATIONAL CORP.
More informationCompliance Program Guidance Manual Chapter 42 Blood and Blood Products
Compliance Program Guidance Manual Chapter 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices Regulated by CBER - 7342.008 Implementation Date: October 1, 2012 PRODUCT
More informationThe Role of Chemists in the FDA Drug Approval Process
The Role of Chemists in the FDA Drug Approval Process 231 st ACS National Meeting Atlanta, GA M. Scott Furness, Ph.D. March 26, 2006 Introduction Presentation Outline FDA Organization CDER Organization
More informationQUALITY AGREEMENT. The following Agreement has been concluded between
QUALITY AGREEMENT The following Agreement has been concluded between LLC LABORATORIES The contract laboratory and service provider 1625 Trinity Dr., Unit 11 Mississauga, Ontario Canada L5T 1W9 Hereinafter
More informationCurrent Good Manufacturing Practice Requirements for Combination Products
[Federal Register: September 23, 2009 (Volume 74, Number 183)] [Proposed Rules] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr23se09-17] -----------------------------------------------------------------------
More informationGuidance for Industry
Guidance for Industry Cooperative Manufacturing Arrangements for Licensed Biologics Additional copies of this guidance are available from the Office of Communication, Training and Manufacturers Assistance
More informationAPEC GCP Inspection Workshop May 29, 2008
Common Investigator Deficiencies Jean Toth-Allen, Ph.D. APEC GCP Inspection Workshop May 29, 2008 Most Common CI Deficiencies Failure to follow the investigational plan Protocol deviations Inadequate recordkeeping
More informationQuality Related to Tracked Safety Issues (TSI) An Ophthalmic Case Study
Quality Related to Tracked Safety Issues (TSI) An Ophthalmic Case Study Avin Lalmansingh, Ph.D. CDER/OPQ/OLDP/ Division of Post marketing Activities II 2017 AAM CMC Workshop May 24 th, 2017 DISCLAIMER
More informationReport on the Performance of Drug and Biologics Firms in Conducting Postmarketing
This document is scheduled to be published in the Federal Register on 11/28/2016 and available online at https://federalregister.gov/d/2016-28442, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationFDA s Role in Vaccine Supply
IOM Committee on Review of Priorities of the National Vaccine Plan Stakeholder Workshop #1 24 July 2008 FDA s Role in Vaccine Supply Norman W. Baylor, Ph.D., Director Office of Vaccines Research and Review
More informationThe FDA Just Arrived... Are You Ready? Presented By Sandra Lueken Sr. Director, Quality AstraZeneca Biologics
The FDA Just Arrived... Are You Ready? Presented By Sandra Lueken Sr. Director, Quality AstraZeneca Biologics Objectives Review Quality Systems Audit Approach and cgmp fundamentals Logistical Audit Preparation
More informationRole of Human Factors Engineering in Medical Products Regulatory Reviews and Research
Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research FDA Small Business Regulatory Education for Industry (REdI) Burlingame, CA May 15, 2018 Kimberly Kontson, Ph.D. Biomedical
More informationThe Device Side of Combination Products
The Device Side of Combination Products Technical and Regulatory Challenges in Life Cycle Management Bob Laughner Associate Director, Combination Products 04 May 2016 What are combination products? Combination
More informationCBER Expectations Regarding Contract Manufacturing
CBER Expectations Regarding Contract Manufacturing LCDR Qiao Bobo, Ph.D. FDA/CBER/OCBQ/DMPQ CASSS CMC Strategy Forum Summer 2014 Outline 2 Types of Cooperative Manufacturing Arrangements CBER Expectations
More informationPET Drug Inspections and Compliance Update
PET Drug Inspections and Compliance Update Society of Nuclear Medicine and Molecular Imaging Annual Meeting San Diego, CA June 14, 2016 Krishna Ghosh, MS, Ph.D. Senior Policy Advisor Center for Drug Evaluation
More informationCompliance Considerations in Pharmaceutical Product Development
Compliance Considerations in Pharmaceutical Product Development John C. (Jack) Garvey, Esq. THE WEINBERG GROUP INC. PRINCETON, NJ Compliance in Drug Development The Drug Development Challenge A Sampling
More informationCBER Regulation of Devices for Cell Therapy
CBER Regulation of Devices for Cell Therapy Richard D. McFarland, Ph.D., M.D. Associate Director for Policy Office of Cellular, Tissue and Gene Therapies Center for Biologics Evaluation and Research Food
More informationInvestigator-Initiated INDs
Investigator-Initiated INDs Marjorie Small, RN, CCRC Office of Clinical Research 23 May 2011 PPHS/IRB Research Grand Rounds Outline of Presentation I. What is an IND? II. Code of Federal Regulations III.
More informationOverview of Inspection Issues with Legacy Products
Overview of Inspection Issues with Legacy Products Presented by Simone E. Pitts Consumer Safety Officer, USFDA Team Biologics simone.pitts@fda.hhs.gov Objective To provide some examples of recent inspectional
More informationCANADA (HEALTH CANADA)
1 GMP GAZETTE TM March 2015 HPFBI CANADA (HEALTH CANADA) Notice, Re: Regulatory Decision Summaries and Submissions Under Review Who s affected? Manufacturers of prescription drugs (pharmaceuticals and
More informationGuidance for Industry
Guidance for Industry Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage DRAFT GUIDANCE This guidance document is being distributed for comment purposes
More informationDocket No. FDA-2015-D-0198: Current Good Manufacturing Practice Requirements for Combination Products.
701 Pennsylvania Avenue, Ste. 800 Washington, DC 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org April 29, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630
More informationFDA Sponsor and Investigator Responsibility Checklist
FDA Sponsor and Investigator Responsibility Checklist Principal Investigator: Study Name: CPHS #: IND/IDE #: Name of IND/IDE holder: The following checklist is created based on the Sponsor and Investigator
More informationExpedited Reporting. Darlene Kitterman, MBA Director, Investigator Support & Integration Services, OCTRI September 25, 2014
Expedited Reporting Darlene Kitterman, MBA Director, Investigator Support & Integration Services, OCTRI September 25, 2014 Journal of Clinical Research Best Practices Vol. 7, No. 1, January 2011 Can You
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Thomas E. Young,
More informationFood and Drug Administration (FDA) 101
Food and Drug Administration (FDA) 101 What is the Food and Drug Administration (FDA)? The FDA is an agency within the U.S. Department of Health and Human Services that is responsible for protecting the
More informationDocket No. FDA-2015-D-0198: Current Good Manufacturing Practice Requirements for Combination Products.
701 Pennsylvania Avenue, Ste. 800 Washington, DC 20004 2654 Tel: 202 783 8700 Fax: 202 783 8750 www.advamed.org April 29, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630
More informationDrug-Device Combination Product Development: INDs for Device Companies
Drug-Device Combination Product Development: INDs for Device Companies David Armbruster Global Program Manager April 24, 2013 Drug-Device Combination Product Development -or- The scenic route to an IND
More informationAugust 14, Dockets Management Staff (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 August 14, 2018 Dockets Management Staff (HFA-305) Food and Drug Administration 5630
More informationGood Manufacturing Practice ( GMP ) Compliance: GMPs EXPLAINED
Good Manufacturing Practice ( GMP ) Compliance: GMPs EXPLAINED Presented by Raymond A. Bonner Nathan C. Sheers SIDLEY AUSTIN BROWN & WOOD, LLP Washington, D.C. (202) 736-8000 To The Fourth Annual Pharmaceutical
More informationGlobal Regulatory Affairs
Navigating the Regulatory Landscape for Combination Products Presented by: Becky Leibowitz, Ph.D. Associate Director, RA-CMC, Medical Devices & Combination Products Janssen Research & Development, LLC
More informationPharmacovigilance and the Generic Industry
Pharmacovigilance and the Generic Industry Presented by Joan Janulis, RAC Vice President Lachman Consultant Services Inc. 2015 Lachman Consultant Services, Inc. All rights reserved. Legal Notice The information
More informationCOMBINATION PRODUCTS Inspection Readiness and Outcomes
WHITE PAPER COMBINATION PRODUCTS Inspection Readiness and Outcomes Many companies think that because they have a good relationship with the FDA Center they interacted with during their submission reviews
More informationApril 12, 2010 WARNING LETTER (10-ATL-12)
Hospira, Inc. Department of Health and Human Services Public Health Service Food and Drug Administration Atlanta District Office 60 8th Street, N.E. Atlanta, Georgia 30309 April 12, 2010 VIA FEDERAL EXPRESS
More informationPHARM 532 Regulation of Pharmaceuticals II
FDA s Regulatory Structuret PHARM 532 Regulation of Pharmaceuticals II Spring 2009 Center(s) for Biologics Evaluation & Research (CBER) 1 Drug Evaluation & Research (CDER) 2 Device & Radiological Health
More informationCombination Products at US FDA
Multimodal Therapies for Brain Disorders: Session II Regulatory and Reimbursement Considerations Combination Products at US FDA Patricia Y. Love, MD, MBA Deputy Director Office of Combination Products,
More informationEstablished Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationUSE OF INVESTIGATIONAL DRUGS OR BIOLOGICS IN HUMAN SUBJECTS RESEARCH
Policy P.11 Written By: B. Laurel Elder Created: June 3, 2013 Edited Replaces 10-9-2009 Version P.11.4 USE OF INVESTIGATIONAL DRUGS OR BIOLOGICS IN HUMAN SUBJECTS RESEARCH A. Procedure Contents this procedure
More informationCombination Products Determination and Review Processes: Impact of 21 st Century Cures Act and Recent FDA Initiatives
Combination Products Determination and Review Processes: Impact of 21 st Century Cures Act and Recent FDA Initiatives Presenters Suzanne O Shea, Director, Navigant Consulting Kirsten Paulson, Senior Director,
More informationCopyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
More informationCANADA (HEALTH CANADA)
LEADERS 1 THE GMP GAZETTE TM February 2015 HPFBI CANADA (HEALTH CANADA) Blood Establishment Registration Application: Form and Instructions - (FRM-0353) Who s affected? Anyone who plans to perform the
More informationModernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture;
This document is scheduled to be published in the Federal Register on 06/29/2018 and available online at https://federalregister.gov/d/2018-14005, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationUT SOUTHWESTERN MEDICAL CENTER AT DALLAS INSTITUTIONAL REVIEW BOARD. Emergency Use of an Investigational Drug, Biologic or Device
Emergency Use of an Investigational Drug, Biologic or Device Introduction The emergency use provision in the FDA regulations (21 CFR 56.102d) is an exemption from prior review and approval by the IRB for
More informationTHE COMPLETE GUIDE TO FDA-REGULATED SUPPLIER QUALIFICATION & QUALITY MANAGEMENT
THE COMPLETE GUIDE TO FDA-REGULATED SUPPLIER QUALIFICATION & QUALITY MANAGEMENT A risk-based approach to qualifying, managing and auditing third party providers TABLE OF CONTENTS 1 Outsourcing under greater
More informationPharmacovigilance and the Generic Industry. Mark Vieder RPh MBA Director, Safety & Medical Writing Biorasi
and the Generic Industry Mark Vieder RPh MBA Director, Safety & Medical Writing Biorasi Disclaimer: This presentation has been prepared by Biorasi, LLC solely for the purpose of sharing information and
More informationImport Admissibility Process. Russell Vandermark Consumer Safety Officer FDA Philadelphia District Import Operations Group
Import Admissibility Process Russell Vandermark Consumer Safety Officer FDA Philadelphia District Import Operations Group Prescription Finished Dosages Drug Approval New Drug Application Entry Validation
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 informationInspections, Compliance, Enforcement, and Criminal Investigations
Seite 1 von 8 Inspections, Compliance, Enforcement, and Criminal Investigations Department of Health and Human Services Public Health Service Food and Drug Administration Center for Biologics Evaluation
More informationOutline. Post-Submission and Post-Approval Requirements. PDUFA/MDUFA-What are they? What I have tried to provide
Outline Post-Submission and Post-Approval Requirements Monica S. Krieger, Ph.D, M.B.A. Vice President, Regulatory Affairs OncoGenex Technologies, Inc. Introduction to PDUFA/MDUFA Amendments to Unapproved
More informationQuality Agreements with CMO s. Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals
Quality Agreements with CMO s Presented at ASQ Orange Empire Meeting May 13, 2014 By Luke Foo Sr. Director QA/QC Spectrum Pharmaceuticals FDA Guidance Contract Manufacturing Arrangements for Drugs: Quality
More informationSupply of IND Agents to Multi-center trials by Skilled Academic Sites
Supply of IND Agents to Multi-center trials by Skilled Academic Sites Paula M. Jacobs, Ph.D. Associate Director, Division of Cancer Treatment and Diagnosis, NCI Cancer Imaging Program June 2016 SNMMI San
More informationManaging Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection
Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! *** REGISTER
More informationDistinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements Draft Guidance for Industry
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 informationPlanning for and Managing FDA Inspections. Focus: 21 CFR, Part 820
Planning for and Managing FDA Inspections Focus: 21 CFR, Part 820 Information, Preventive Action and Strategy 1 The Authority behind Inspections The Safe Medical Devices Act of 1990 (the SMDA), enacted
More informationInspections and ANDA Review: CDER/OC/OMQ s Role
Inspections and ANDA Review: CDER/OC/OMQ s Role Francis Godwin, Acting Director Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research GPhA 2016 Fall Technical Conference
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 informationDEC DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Ms. Victoria Rendon Senior
More informationUNCONTROLLED DOCUMENT WHEN PRINTED
1. PURPOSE 1.1. The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for receiving, processing, and investigating customer complaints. 2. APPLICATION
More informationNavigating an FDA GMP and Validation Inspection- Best Practices and Pitfalls
Navigating an FDA GMP and Validation Inspection- Best Practices and Pitfalls Sonali P. Gunawardhana FDA Practice Group Wiley Rein LLP 1776 K Street NW Washington, DC (202) 719-7454 sgunawardhana@wileyrein.com
More informationU.S. DRUG SAFETY : Compliance Basics
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. U.S. DRUG SAFETY : Compliance Basics Scott Bass Sidley
More informationOctober 10, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
October 10, 2017 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2017 D 2802: Chemistry, Manufacturing, and Controls
More informationPre-Approval Inspections for Drug Products
Pre-Approval Inspections for Drug Products FDA Small Business Regulatory Education for Industry Conference June 20, 2013 H.L. Jamillah Selby Consumer Safety Officer FDA, Dallas District Office Presentation
More informationSonja Brajovic Medical Officer, Office of Surveillance and Epidemiology Center for Drug Evaluation and Research Food and Drug Administration
FDA Perspective on MedDRA Coding Quality in Post marketing Safety Reports European Informal MedDRA User Group Webinar Sonja Brajovic Medical Officer, Office of Surveillance and Epidemiology Center for
More informationReplacing Analytical Methods for Release and Stability Testing CBER Perspective
Replacing Analytical Methods for Release and Stability Testing CBER Perspective Presentation at the CMC Strategy Forum January 27, 2014 Lokesh Bhattacharyya Chief, Lab of Analytical Chemistry and Blood
More informationAPR Dear Ms. Adair:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 2 7 2004 Ms. Kaoru L. Adair Vice President Regulatory Affairs and
More informationMedical Device Postmarket Compliance in the United States
Articles July 22, 2013 Medical Device Postmarket Compliance in the United States Introduction Once the U.S. Food and Drug Administration (FDA or the agency ) has cleared or approved a medical device for
More informationFDA Inspections: FDA Inspections: An Overview Overview
FDA Inspections: An Overview Robert Lindblad, MD The EMMES Corporation August 11, 2011 researchcartoons.com Why Inspections? Why Inspections? To evaluate compliance with regulations To establish that an
More informationELEMENTS OF A DATA MONITORING PLAN
ELEMENTS OF A DATA MONITORING PLAN Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and
More informationQuality Assurance for the Research Team: Connecting Day-to-Day Operations to a Regulatory Framework
1 Quality Assurance for the Research Team: Connecting Day-to-Day Operations to a Regulatory Framework Mandy Morneault Research Compliance Monitor University of Washington Institute of Translational Health
More informationMarch 4, Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm Rockville, MD 20852
March 4, 2014 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket No. FDA 2013-N-1523: Request for Nominations: Drug Products that
More informationInspections, Compliance, Enforcement, and Criminal Investigations
Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations Celltex Therapeutics Corporation
More informationDEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002 Lauren Baker, Ph.D. DEC
More informationGuidance for Clinical Investigators, Sponsors, and IRBs
Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection u.s. Department of Health and Human Services Office of the Commissioner (OC) Center
More informationSupply Chain Supplier Quality Management. Nicholas Violand, Investigator/Drug Specialist US FDA, New Jersey District
Supply Chain Supplier Quality Management Nicholas Violand, Investigator/Drug Specialist US FDA, New Jersey District 1 Overview Product Life Cycle Maintaining Quality in Supply Chain FDA and ICH Guidances
More informationRe: Comments on Unique Device Identification System; Proposed Rule; Docket No. FDA-2011-N-0090 / RIN No AG31
1227 25th Street, NW Washington, D.C. 20037-1156 October 24, 2012 VIA ELECTRONIC SUBMISSION Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville,
More informationReporting Deviations of Biological Products and HCT/Ps. Ellen Areman Senior Consultant Biologics Consulting Group, Inc.
Reporting Deviations of Biological Products and HCT/Ps Ellen Areman Senior Consultant Biologics Consulting Group, Inc. Relevant Legislation Public Health Service (PHS) Act Regulates biological products
More information