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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Levitra Not Withdrawn Over Safety/Efficacy: FDA

Federal Register notice: FDA determines that Bayers Levitra (vardenafil hydrochloride) tablets, 2.5mg, were not withdrawn from sale for safety or effe...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.