For Immediate Release: April 24, 2024 Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary […]

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try […]

An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, […]

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 […]

12/05/2022 Thriftmaster Texas, LLC. d/b/a ThriftMaster Global Holdings, Inc. and TM Global Biosciences, LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated […]

   Subscribe to receive FDA health fraud alerts Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but […]

Latest Update April 25, 2024 – FDA will be hosting an in-person advisory committee meeting in fall 2024 to discuss reevaluation of the Clozapine risk evaluation […]

Ojemda (tovorafenib) Patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 […]

What are the main differences between an FDA inspection of a 503A and 503B compounding facility? What is the difference between a surveillance inspection, a for-cause […]