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FDA Amends Dates on Device ID System Rule

11/19/2012

Federal Register Proposed rule: FDA is amending its 7/10 proposed rule (77 FR 40736) to establish a unique device identification (...

Comments Sought on Custom Device Exemption

11/19/2012

Federal Register Notice: FDA is seeking information on and examples of appropriate uses of the custom device exemption identified ...

FDA Publishes Notice of FDA User Fee System Records

11/14/2012

Federal Register Notice: FDA is publishing notice of a Privacy Act system of records entitled, “FDA User Fee System, HHS/FDA...

Panel to Discuss NDA for Chronic Fatigue

10/22/2012

Info on Rx Drug User Fee Form Sent to OMB

10/22/2012

Federal Register Notice: FDA’s collection of information, “Prescription Drug User Fee Cover Sheet; Form FDA 3397,&rdqu...

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5 Drug Products Not Withdrawn for S&E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