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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...

Workshop on Device Postmarket Risk

03/19/2015

Federal Register Notice: FDA will hold a public workshop 4/21 entitled “Clinical Considerations of Risk in the Postmarket En...

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...

Comments Sought on State Enforcement Notifications

03/13/2015

Federal Register Notice: FDA is seeking public comment on reporting requirements contained in existing FDA regulations governing s...

Comment Period Extended on Combo Products Guidance

03/13/2015

Federal Register Notice: FDA is extending the comment period to 4/29, for the draft guidance: Current Good Manufacturing Practice ...

Panel to Discuss Hearing Devices

03/13/2015

Federal Register Notice: FDA’s Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee will meet 4/30-...

Panel to Discuss Duodenoscope Infections

03/13/2015

Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel will meet 5/14-15, from 8 a.m. to 6 p.m. at the FD...