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Human Drugs

ICH Daily Exposure Maintenance Procedures

FDA makes available International Council on Harmonization maintenance procedures for revising the permitted daily exposure of solvents included in it...

Federal Register

FDA Workshop on Device Quality Pilot Program

FDA announces a 10/10 public workshop on Voluntary Medical Device Manufacturing and Product Quality Program to announce a proposed framework and preli...

Human Drugs

FDA Guide on Generic User Fee Questions & Answers

FDA posts a guidance on Generic Drug User Fee Amendments of 2012 Questions and Answers that provides answers to certain issues arising from the imple...

Medical Devices

1st Patient Engagement Committee Meeting Set

FDA says the first meeting of the new Patient Engagement Advisory Committee will focus on patient perspectives on clinical trial design, conduct, and ...

Federal Register

FDA Re-org Moves Lab Science/Safety Under Commissioners Office

Federal Register notice: FDA announces a restructuring of its Office of the Commissioner, and Office of Operations.

Federal Register

Guidance on Animal Drug User Fee Waivers

Federal Register notice: FDA announces the availability of a guidance for industry on Animal Drug User Fees and Fee Waivers and Reductions.

Human Drugs

Small Business Consumer Antiseptic Wash Guidance

FDA publishes a guidance to help small businesses understand and comply with a final rule on consumer antiseptic wash product ingredients.

Human Drugs

Cantrell Recalling All Sterile Drug Products

FDA says Cantrell has recalled all lots of unexpired sterile drug products due to a lack of sterility assurance.

Human Drugs

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Option Care, Sage Products and Whitehall/Acorn Engineering.

Human Drugs

FDA Approves Teligents ANDA for Topical Erythromycin

FDA approves a Teligent ANDA for generic erythromycin topical gel, an antibiotic for treating skin infections.