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Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies

U.S. Food and Drug Administration

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8.8K views 3 years ago

8,888 views • Jun 29, 2021

CDER’s Paul Gouge, JD, provides background on Investigational New Drug (IND) safety reporting and describes the new guidance entitled, “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” _______________________________  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367 ...more

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Chapters

These chapters are auto-generated

Intro

0:00

Guidance Timeline of IND Safety Reporting Policy Development

1:33

Background: 2010 Final Safety Reporting Rule

2:53

IND Safety Reporting Final Rule (21 CFR Part 312.32)

3:48

IND Safety Guidance Development

4:38

IND Safety Reporting Overview: What Does the 2010 Rule Address?

9:06

IND Safety Reports 15 and 7 Day

10:08

Types of IND Safety Reports

11:12

Overview of Aggregate Data Analyses

13:49

Aegregate Analyses: Trieger Approach Determining Rates of Anticipated Events

17:34

Flowchart: Appendix C Two Approaches to Aggregate Analyses

19:18

Flexibility in Who Should Review Safety Information for IND Safety Reporting

22:46

Use of DMC to Review Aggregate Data

24:35

Unblinding of Safety Data and Implications for DA

25:01

Safety Surveillance Plan

26:31

Clarifies IND Safety Reporting for Marketed Drugs and Active Control

27:44

IND Safety Reports - Electronic Submission Process

29:07

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Description

Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies

N/ALikes

8,888Views

2021Jun 29

CDER’s Paul Gouge, JD, provides background on Investigational New Drug (IND) safety reporting and describes the new guidance entitled, “Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” _______________________________  FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.     Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2021 Playlist -    • 2021 CDER Small Business and Industry...   SBIA LinkedIn:   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - CDERSBIA@fda.hhs.gov   Phone - (301) 796-6707 I (866) 405-5367

Chapters

View all

Intro

0:00

Guidance Timeline of IND Safety Reporting Policy Development

1:33

Background: 2010 Final Safety Reporting Rule

2:53

IND Safety Reporting Final Rule (21 CFR Part 312.32)

3:48

Transcript

Follow along using the transcript.

Show transcript

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