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Meeting on FDA’s Plan on Demographic Subgroup Data

01/06/2016

Federal Register Notice: FDA Office of Minority Health, Office of Women’s Health, CBER, CDER, and CDRH will hold a public me...

Intravaginal Culture System into Class 2

01/06/2016

Federal Register Final order: FDA is classifying the intravaginal culture system into Class 2 (special controls). The special cont...

Panel to Discuss Leadless Cardiac Pacemakers

12/14/2015

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 2/18/16,...

Review Period Set for Sirturo

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Janssen Pharmaceutica’s Sirturo is 2,213 days f...

Review Period Set for Eliquis

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Eliquis is 3,685 days fo...

Review Period Set for Visual Stimulation System

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Second Sight Medical Products’ Argus II Visual ...

Review Period Set for Bayer Animal Health’s Veraflox

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Bayer Animal Health’s Veraflox is 3,285 days fo...

Comments Sought on ‘Enhanced Transparency’ Submissions

12/10/2015

Federal Register Notice: FDA is seeking public comment on a proposed information collection involving interviews of pharmaceutical...

FDA Sets Review Period for Fulyzaq

12/10/2015

Federal Register Notice: FDA has determined the regulatory review period for Napo Pharmaceuticals’ Fulyzaq is 7,784 days for...

Guidance on Blood Donor Suitability in Ebola Outbreaks

12/03/2015

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Assessment of Blood Donor Suitabili...