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Latest posts

Last updated about 11 hours ago

Novel Drug Approvals for 2026

about 11 hours ago

Novel Drug Approvals for 2026

FDA Approves First Treatment for Children With Menkes Disease

about 11 hours ago

The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate)...

Apetamin — An Illegally Imported Weight Gain, Figure Augmentation Product

about 13 hours ago

Apetamin, a brand name product, is manufactured overseas and illegally imported to...

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

4 days ago

Rosemead, CA, ANTHONY TRINH, 123herbals LLC is voluntarily recalling all lots of...

Final Report FDA-EMA pilot program for the parallel assessment of quality-by-design elements of marketing applications

4 days ago

Final Report from the FDA-EMA pilot program for the parallel assessment of...

Human Drug Imports

4 days ago

Human drug import information including PLAIR, safe importation action plan, and personal...

Importing Liquid Cough and Cold Medicine from India

4 days ago

FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG)...

Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products

4 days ago

This draft guidance provides guidance to sponsors and applicants submitting investigational new...

FDA In Brief: 2016 annual summary report of sales and distribution data for antimicrobial drugs intended for use in food-producing animals

5 days ago

FDA’s annual report summarizing 2016 sales and distribution estimates for antimicrobial drugs...

FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

5 days ago

The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride...