Natco Pharma Limited – 672564 – 04/08/2024
CGMP/Finished Pharmaceuticals/Adulterated
Some Homeopathic Products May Put You at Risk
Homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling. Learn…
E20 Adaptive Designs for Clinical Trials
E20 Adaptive Designs for Clinical Trials
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional…
Hiding in Plain Sight: 7-OH Products
7-OH: Emergence of a Fourth Opioid Epidemic
FDA approves new treatment for acromegaly, a rare endocrine disorder
The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an…
FDA Focuses on Closing the Clinical Trial Reporting Gap for Research Integrity
The FDA is committed to ensuring data transparency by promoting timely registration and reporting of results information to ClinicalTrials.gov.
MedWatch Forms for FDA Safety Reporting
Safety reporting portal for health professionals, patients, consumers and industry. Find pdf fillable forms in English and Spanish and a…
Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned – 09/23/2025
Opening Remarks by Sara Brenner, U.S. Food and Drug Administration September 23, 2025
FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
On September 25, 2025, the Food and Drug Administration approved imlunestrant (Inluriyo, Eli Lilly and Company), an estrogen receptor antagonist,…