[09-26-2024] The U.S. Food and Drug Administration is advising consumers not to purchase or use Amazy, a product promoted and sold for pain on various websites, including […]

[09-26-2024] The U.S. Food and Drug Administration is advising consumers not to purchase or use Ácido Hialurónico (or Acid Hyaluronic), a product promoted and sold for pain […]

Stop distributing unapproved drugs included in kits On September 20, 2024, FDA requested Azurity Pharmaceuticals Inc. stop distributing unapproved drugs marketed as “Unit-of-Use Prescription Compounding Kits,” […]

Summary Company Announcement Date: October 22, 2019 FDA Publish Date: October 22, 2019 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Tadalafil Company Name: […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]

On September 25, 2024, the Food and Drug Administration approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, unresectable (stage III) non-small cell lung […]

The current legislative authority for BsUFA, authorized in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA) will expire in September 2017. The […]

Drug Sponsor Sponsor Medical Review Clinical Pharmacology Review Statistical Review BPCA or PREA or Both Abametapir – Xeglyze HATCHTECH PTY LTD Medical (PDF – 4 MB) Addendum (PDF […]

Pharmaceutical quality is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of their medications. The Center for Drug Evaluation […]