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Public Meeting on Patient-Focused Drug Development for Bleeding Disorders

07/09/2014

Federal Register Notice: FDA will hold a public meeting 9/22 on Patient-Focused Drug Development for Hemophilia A, Hemophilia B, v...

Participants Sought to Select CBER Panel Reps

07/09/2014

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selection of a nonvo...

OMB OKs Info on Importer’s Entry Notice

06/26/2014

Federal Register Notice: FDA’s collection of information entitled “Importer's Entry Notice” has been approved by...

Panel to Discuss Baxter’s HyQvia

06/26/2014

Federal Register Notice: FDA’s Blood Products Advisory Committee will meet 7/31, from 8 a.m. to 5 p.m. at the FDA White Oak ...

Comments Sought on Device Pilot Program

06/26/2014

Federal Register Notice: FDA is seeking public comment on information collection associated with the Medical Device ISO 13485:2003...

Comments Sought on Bioequivalence Studies Info

06/26/2014

Federal Register Notice: FDA seeks comments on the requirement for an ANDA applicant to submit data from all bioequivalence studie...

Panel to Discuss Cohera’s TissuGlu

06/26/2014

Federal Register Notice: FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee will meet...

Panel to Discuss Boehringer NDA for COPD

06/26/2014

Info on Medicated Feeds CGMPs Sent to OMB

06/20/2014

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice Regulations fo...

Info on Minor Species Drugs Sent to OMB

06/20/2014

Federal Register Notice: FDA’s proposed collection of information, “Index of Legally Marketed Unapproved New Animal Dr...