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Workshop on Electronic Databases for Drug Safety Info

04/17/2015

Federal Register Notice: FDA and the University of Maryland Center for Excellence in Regulatory Science and Innovation will co-spo...

Review Period Set for Ravicti

04/17/2015

Federal Register Notice: FDA has determined the regulatory review period for Hyperion Therapeutics’ Ravicti is 2,126 days fo...

Info on Rx Drug Ad Price Info Sent to OMB

04/06/2015

Federal Register Notice: FDA’s proposed collection of information, “Comparative Price Information in Direct-to-Consume...

Info on Device Labeling Sent to OMB

04/06/2015

Federal Register Notice: FDA’s proposed collection of information, “Survey of Health Care Practitioners for Device Lab...

Blood Products Panel to Meet

04/06/2015

Federal Register Notice: FDA’s Blood Products Advisory Committee will meet 5/13, from 8 a.m. to 5:30 p.m. at the FDA White O...

FDA Plans Clinical Trial Education Conference in OH

04/06/2015

Federal Register Notice: FDA will co-sponsor an educational conference with the Society of Clinical Research Associates 5/13-14 fr...

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 ...