2023 Drugs and Biologics Year in Review: Will FDA’s 2023 Evolution Usher in Swift Resolutions for 2024?

Lexology January 9, 2024
Morgan, Lewis & Bockius LLP

REPORT

2023 DRUGS AND BIOLOGICS YEAR IN REVIEW

Will FDA’s 2023 Evolution Usher in Swift Resolutions for 2024?

www.morganlewis.com

2024 Morgan Lewis | Morgan, Lewis & Bockius LLP, a Pennsylvania limited liability partnership 1

2023 DRUGS AND BIOLOGICS YEAR IN REVIEW: WILL FDA’S 2023 EVOLUTION USHER IN SWIFT RESOLUTIONS FOR 2024?

TABLE OF CONTENTS

Introduction FDA Drug and Biologic Development Guidance

Good Clinical Practices/Clinical Trial Conduct Clinical Trial Design FDA Review of Clinical Trials Combination Product Guidance Oncology-Focused Guidance Process Guidance Drug Manufacturing Advertising and Promotion Labeling Drug Supply Chain Security Act Implementation and Compliance Conclusion Contacts

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2024 Morgan Lewis

2 www.morganlewis.com

2023 DRUGS AND BIOLOGICS...

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