Quick Links This page provides quick links to key guidances to support the submission of study data to FDA’s Center for Biologics Evaluation and Research (CBER), […]

[embedded content] Español 简体中文   한국어   Tagalog   Việt While we remain vigilant to protect our families and communities from the spread of COVID-19, some […]

Summary Company Announcement Date: April 04, 2024 FDA Publish Date: April 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Non-compliance with current good […]

AUTHORITY The Arthritis Advisory Committee (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, […]

English    Español (Spanish)    CDC COVID-19 Communication Toolkit: For Migrants, Refugees, and Other Limited-English-Proficient Populations in various languages 미식품의약국 (FDA)으로부터 코비드-19 (COVID-19) 백신에 대하여 더 많이 배우십시 (Learn […]

Docket Number: FDA-2023-D-4719 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This FDA guidance provides information to sponsors and nonclinical laboratories regarding the […]

Docket Number: FDA-2019-D-1264 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Over the past few decades, FDA […]

1995.  OxyContin (oxycodone controlled-release) approved; first formulation of oxycodone that allowed dosing every 12 hours instead of every 4 to 6 hours.   1998.  Actiq (fentanyl) […]

For Immediate Release: April 03, 2024 Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with […]