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Case Study in Corruption: Jeff Shuren’s CDRH

10/03/2023

“Power tends to corrupt and absolute power corrupts absolutely.” (Lord Acton in 1887) [Analysis by Jim Dickinson] Supp...

FDA Renews, Expands Certara Software

10/13/2020

FDA has renewed and expanded its licenses of Certara’s biosimulation software with more than 400 user licenses of the compan...

FDA Labeling Policies Blamed for IUD Damage to Women

09/22/2020

[Report by Jim Dickinson] Years of complaints about the adequacy of CDRH device labeling requirements are echoed in a new raft of ...

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...