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Grant Funds Available for Orphan Products

08/06/2012

Federal Register Notice: FDA is announcing the availability of grant funds to support FDA’s Office of Orphan Products Develo...

Info on Labeling Non-Rx Drugs Sent to OMB

07/26/2012

Comments Sought on Generic Drug User Fee Collection of Info

07/26/2012

Pediatric Devices Workshop Slated

07/26/2012

Federal Register Notice: FDA’s Office of Orphan Products Development is will hold the FDA Pediatric Medical Devices Workshop...

Info on Investigator Financial Disclosure Sent to OMB

07/26/2012

Federal Register Notice: FDA’s proposed collection of information, “Financial Disclosure by Clinical Investigators,&rd...

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...

FDA Cancels Dispute Panel Meeting on Ethicon Sedasys PMA

12/05/2011

Federal Register Notice: The 12/14 meeting of the Medical Devices Dispute Resolution Panel is canceled. The meeting was slated to ...

5 Drug Products Not Withdrawn for S&E

12/05/2011