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Review Period Set for Luzu

04/22/2016

Federal Register Notice: FDA has determined the regulatory review period for Nihon Nohyaku Co.’s Luzu is 2,242 days for exte...

FDA Extends Comments on 4 HCT/P Guidances

04/22/2016

Federal Register Notice: FDA is extending the comment period for the draft guidance documents entitled Same Surgical Procedure Exc...

FDA Issues EUA for Zika Diagnostic

04/22/2016

Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus ...

Hearing on HCT/P Draft Guidances

04/22/2016

Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating ...

Comments Extended on Investigational Mosquitoes

04/14/2016

Federal Register Notice: FDA is extending the comment period for a 3/14 Federal Register notice that requested comments on the Dra...

Panel to Discuss St. Jude Medical PMA for Stroke Patients

04/13/2016

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24, fr...

Bone, Reproductive & Urologic Panel Renewed

04/06/2016

Federal Register Notice: The FDA commissioner is renewing the Bone, Reproductive and Urologic Drugs Advisory Committee for an addi...

FDA Changes Date of Endocrinologic/Metabolic Drugs Panel Meeting

04/06/2016

Federal Register Notice: FDA is amending the notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to r...

FDA Changes Date of Panel Meeting

04/06/2016

Federal Register Notice: FDA is amending a notice of a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee announ...

Animal Drug Regs Reflect 2015 Actions

03/30/2016

Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANAD...