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Last updated 1 day ago

Postmarketing Requirements and Commitments: Reports

1 day ago

The Food and Drug Administration Modernization Act of 1997 requires FDA to...

FDA Responses to Action Items Identified in 2023 Intergovernmental Working Meeting on Drug Compounding

1 day ago

In the most recent Intergovernmental Working Meeting on Drug Compounding, Nov. 7-8...

Inter-governmental Working Meeting on Drug Compounding | November 7-8, 2023

1 day ago

Inter-governmental Working Meeting on Drug Compounding | November 7-8, 2023

M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

1 day ago

This draft guidance describes the scientific and technical aspects of study design...

Project Orbis

2 days ago

Information Project Orbis, an initiative of the FDA Oncology Center of Excellence...

Medgel Private Limited - 654085 - 05/22/2025

3 days ago

CGMP/Finished Pharmaceuticals/Adulterated

Medgel Private Limited - 654085 - 07/20/2023

3 days ago

CGMP/Finished Pharmaceuticals/Adulterated

Newly Added Guidance Documents

3 days ago

Guidance documents represent the FDA's current thinking on a particular subject. New...

Replacing Color Additives in Approved or Marketed Drug Products

3 days ago

This draft guidance provides recommendations for replacing color additives in approved or...

Advances in FDA's Drug Safety Programs

3 days ago

Drug Safety is a Key Priority at the Center for Drug Evaluation...

Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present

3 days ago

The following are the medical, statistical, and clinical pharmacology reviews of pediatric...

FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces - 05/29/2025

3 days ago

Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces, May 29...