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Comments Sought on Antiparasitic Drug Info

12/03/2012

Federal Register Notice: FDA is seeking public comment on its proposed collection of information entitled “Antiparasitic Dru...

Info on IDE Reports Sent to OMB

12/03/2012

Federal Register Notice: FDA’s proposed collection of information, “Investigational Device Exemptions Reports and Reco...

Comments Sought on Biological Product Constituent Materials

11/29/2012

Federal Register Notice: FDA is seeking comments on a proposed collection of information, “Revision of the Requirements for ...

Panel to Discuss Shortwave Diathermy Device Reclassification

11/29/2012

Federal Register Notice: FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will me...

Guidance on Preclinical Info for Cellular and Gene Therapy Products

11/29/2012

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Preclinical Assessment of Investigationa...

FDA Posts Planned CDRH Guidances

11/26/2012

Federal Register Notice: FDA is posting two lists on its Web site of CDRH guidance documents planned for FY 2013. Also, it has est...

Risk Communication Advisory Panel to Meet

11/26/2012

Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/12, from 8 a.m. to 3 p.m. at the FDA White ...

Public Meeting on Generic Drug User Fee Act

12/08/2011

Federal Register Notice: FDA will hold a public meeting 12/19 to discuss proposed recommendations for enacting a Generic Drug User...

Info on MedWatch Sent to OMB

12/07/2011

Federal Register Notice FDA is announcing that a proposed collection of information, “MedWatch: The FDA Medical Products Rep...

Meeting to Discuss Biosimilar Biologic User Fees

12/07/2011

Federal Register Notice: FDA will hold a public meeting 12/16 to discuss the proposed recommendations for a user fee program for b...