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Comments Sought on Device User Fee Form

06/06/2012

Federal Register Notice: FDA is seeking comments on a proposed collection of information by the agency, “Form FDA 3601 &mdas...

Surrogate Endpoints for Breast Cancer Drug Accelerated Approval

05/30/2012

Federal Register Notice: FDA is making available a draft guidance for industry entitled Pathologic Complete Response in Neoadjuvan...

Animal Drug Sponsor Changed to Elanco

05/30/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 17 NADAs and ANADAs fo...

FDA to Consider Vaccine Trial Cooperative Agreement

05/16/2012

Federal Register Notice: FDA announces its intention to accept and consider a single source application for an award of a cooperat...

OTC Sunscreen Compliance Dates Delayed

05/11/2012

Federal Register Final rule: FDA is delaying the compliance dates for the 6/17/11 final rule for OTC sunscreen drug products that ...

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5 Drug Products Not Withdrawn for S&E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