Collaborating with States FDA’s compounding program closely collaborates with state officials in a variety of ways, including: sharing information about compounders who engage in poor practices […]

Effective communication among ANDA applicants, DMF holders, and FDA is essential for reducing the likelihood of potential problems that could delay approvals. The reauthorization of the […]

GDUFA Guidance for Industry To view all GDUFA guidances, go to the Guidances for Drugs page, enter “GDUFA” in the search box, and under “Filter by,” […]

5/21/2024 Drug Approval Package: JAYPIRCA 11/9/2023 First Interchangeable Exclusivity Expiration Memorandum for Cyltezo October 3, 2023 (PDF – 1.41MB) 5/15/2023 Adverse event report for Syfovre (PDF […]

Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Jose L. Escobedo Recipient Title Manufacturing Operations Manager Central Admixture Pharmacy Services, Inc. 2200 […]

On this page As announced in the Federal Register notice published on October 20, 2022, FDA is conducting an Advancing Real-World Evidence (RWE) Program, which seeks […]

More Than an Estimated 6 Million People Aged 12 or Older Have Opioid Use Disorder Many primary care providers likely already provide medical care to people […]

Image By: Hilary Marston, MD, MPH, Chief Medical Officer and Kevin Bugin, PhD, Deputy Director of Operations in the Office of New Drugs, Center for Drug […]

On this page Screening and Diagnosing Opioid Use Disorder in Primary Care Settings An estimated 6.1 million people over the age of 12 have an opioid […]