Regulatory Developments July 2024

Combination Products

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Draft

7/08/2024

ICH - Multidisciplinary

M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

Draft

7/05/2024

Biosimilars

Considerations in Demonstrating Interchangeability With a Reference Product: Update

Draft

6/21/2024

Generic Drugs

Facility Readiness: Goal Date Decisions Under GDUFA

Final

6/18/2024

Clinical/Antimicrobial

Diabetic Foot Infections: Developing Drugs for Treatment

Final

6/17/2024

Clinical - Medical

Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics

Final

6/14/2024

Safety - Issues, Errors, and Problems

REMS Logic Model: A Framework to Link Program Design With Assessment

Draft

5/07/2024

Generic Drugs

Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs

Draft

4/29/2024

Drugs

Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry

Draft

4/24/2024

Generic Drugs

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies

Draft

4/03/2024

Generic Drugs

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

Final

4/01/2024

Electronic Submissions

Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry

Final

4/01/2024

Generic Drugs

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products

Draft

7/08/2024