Module 5 Presentations

18/07/2024

CFR Overview

TITLE 21 FOOD & DRUGS

Chapter I Food & Drug Administration

Chapter II Drug Enforcement Administration

Chapter III Office of National Drug Control Policy

Subchapter A General

Subchapter B Food for Human Consumption

Subchapter C Drugs: General

Subchapter D Drugs for Human Use

Subchapter E Animal Drugs, Feeds & Related Products

Subchapter F Biologics

Subchapter G Cosmetics

Subchapter H Medical Devices

Part 807 Establishment Registration Part 801 Labelling Part 803 Device (AE) Reporting

Part 3 Product Jurisdiction

Part 312 IND

Part 601 Licensing

Part 201 Labelling

Part 11 Electronic Records & Signatures Part 50 Protection of Human Subjects Part 54 Financial Disclosure by Clinical Investigators Part 56 Institutional Review Boards

Part 606 Current GMP for blood & blood products

Part 314 NDA

Part 202 Rx Drug Advertising

Part 809 IVD

Part 316 Orphan Drugs

Part 211 GMP -finished product Part 210 Current GMP - general

Part 810 Recall Authority

Part 320 Bioavailability & Bioequivalence

Part 812 IDE

Part 814 Premarket Approval

Part 330 OTC products - GRAS

Part 58 GLP for Nonclinical Laboratory Studies

Part 820 QSR

Part 822 Postmarket Surveillance

The Organisation for Professionals in Regulatory Affairs

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Types of IND Applications ● INDs are specific to a product and indication

– A different indication requires a different IND application ● Original IND (21 CFR 312.23): New application and contains all modules of an IND (Modules 1 – 5) ● Cross-reference IND (21 CFR 312.23(b): New application but relies on previously submitted information in an existing IND [e.g., Module 3 and Module 4 information is not included in the new IND] ● IND Amendment : New/updated information is submitted to an approved IND application. There are 2 categories of IND amendments:

– Protocol Amendment (21 CFR 312.30) – Information Amendment (21 CFR 312.31)

The Organisation for Professionals in Regulatory Affairs

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