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Workshop on Cardiovascular Metallic Implants

02/06/2012

Federal Register Notice: FDA will hold a public workshop 3/8-9 entitled “Cardiovascular Metallic Implants: Corrosion, Surfac...

FDA OKs Novartis sNADA for Canine Dental Pain

01/26/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Novartis Animal Health U.S., Inc...

Comments Sought on Notification Procedure for GRAS Substances

01/18/2012

Federal Register Notice: FDA is seeking public comment on the information collection provisions of the Notification Procedure for ...

Guidance on Knee Cartilage Repair Products

01/18/2012

Federal Register Notice: FDA is making available Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repa...

Prezista Tablets Not Withdrawn for S&E

01/18/2012

Info on E-Submission of Device Registration/Listing Sent to OMB

01/13/2012

List of Approved PMAs Posted

01/13/2012

Federal Register Notice: FDA is publishing a list of PMAs that have been approved to inform the public of the availability of safe...

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...