May 22, 2019
Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions
Apr 24, 2019
FDAnews Announces -- Post-Market Surveillance: How FDA Regulates Your Medical Product after Launch Workshop June 28, 2019 Washington, DC
Apr 11, 2019
FDA orders important safety labeling changes for Addyi
Apr 04, 2019
FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients' responses to specific medications
Mar 29, 2019
Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA's Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA's Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access -Looking Forward
Mar 18, 2019
FDAnews Announces -- Pharmaceutical Data Integrity Webinar, April 02, 2019
Mar 12, 2019
FDAnews Announces -- Post-Market Surveillance: The New World of Compliance, Liability and Best Practices Program on May 16, 2019 in Washington, DC
Mar 07, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA's steps on naming of biological medicines to balance competition and safety for patients receiving these products
Mar 06, 2019
FDAnews Announces -- OTC Regulation: Latest Developments and Best Practices Webinar, March 18, 2019
Feb 26, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA's modern approach to advanced pharmaceutical manufacturing
Feb 21, 2019
FDA advances new proposed regulation to make sure that sunscreens are safe and effective
Feb 13, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
Jan 30, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of the Orange Book to foster drug competition
Jan 16, 2019
FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
Jan 09, 2019
The Future of FDA's Electronic Safety Surveillance
Dec 13, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA's Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development
Nov 16, 2018
Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA's efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs
Oct 23, 2018
Federal judge enters consent decree against Tennessee over-the-counter drug manufacturer
Oct 23, 2018
FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
Oct 22, 2018
Food and Drug Administration (FDA) Approval of GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences' EPIDIOLEX® (cannabidiol) CV Marks First Drug Approval and Scheduling Decision Supported by Analgesic Solutions' MADDERS® System