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Review Period Set for Juxtapid

04/06/2015

Federal Register Notice: FDA has determined the regulatory review period for Aegerion Pharmaceuticals’ Juxtapid (lomitapide ...

FDA Changes Advisory Panel Name

04/06/2015

Federal Register Final rule: FDA is amending the standing advisory committees’ regulations to change the name of the Anti-In...

Urethral Insert into Class 2

04/06/2015

Federal Register Final order: FDA is classifying the urethral insert with pump for bladder drainage into Class 2 (special controls...

Selectors/Nominations Sought for FDA Advisory Panels

04/03/2015

Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting ...

CBER Updates its Addresses in Regulations

04/03/2015

Federal Register Final rule: FDA is amending its regulations to update address information for CBER as a result of the recent relo...

Comments Extended on Biomarkers for Drug Development

04/03/2015

Federal Register Notice: FDA is extending the comment period until 5/15 for identifying potential biomarkers for qualification and...

Guidance on Residual Solvent in Animal Drugs

04/03/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Residual Solvents in Animal Drug Products; Quest...

FDA Holds Statistics Forum

03/25/2015

Federal Register Notice: FDA is co-sponsoring with the Drug Information Association a public conference entitled “Ninth Annu...

Guidance on Gene Therapies, Vectored Vaccines Etc.

03/24/2015

Federal Register Notice: FDA is making available a document entitled Determining the Need for and Content of Environmental Assessm...

CDER Posts Report on Drug Safety Priorities

03/19/2015

Federal Register Notice: FDA is making available a report entitled “Assessing CDER’s Drug Safety-Related Regulatory Sc...