Federal Register
Public Meeting Seeks Input to Improve CDER Reviews
Federal Register notice: FDA announces an 11/7 public meeting entitled Promoting Effective Drug Development Programs: Opportunities and Priorities for...
Federal Register
Levitra Not Withdrawn Over Safety/Efficacy: FDA
Federal Register notice: FDA determines that Bayers Levitra (vardenafil hydrochloride) tablets, 2.5mg, were not withdrawn from sale for safety or effe...
FDA General
FDA Warning on Miracle Mineral Solution
FDA issues a warning against Miracle Mineral Solution because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis an...
Human Drugs
Dare Bio Advancing Bacterial Vaginosis Therapy
FDA grants Dare Bioscience a qualified infectious disease product designation for its bacterial vaginosis therapy.
Medical Devices
Fresenius Kabi Recalls Infusion Pumps
Fresenius Kabi recalls its Volumat MC Agilia Infusion Pumps and Vigilant Agilia Drug Library due to alarm and multiple software errors.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 8/9/2019.
FDA General
Since Our last Issue ...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 8/9/2019.
Human Drugs
Suit Seeks Info on Any Sharpless Drug Conflict
Watchdog group Restore Public Trust files suit to get FOI documents on whether FDA acting commissioner Ned Sharpless is asserting any influence at the...
Human Drugs
Public Meeting Seeks Priorities for New Drug Review
FDA says it is planning an 11/7 public meeting to seek input on opportunities and priorities for CDERs Office of New Drugs.
