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Panel to Discuss Astellas NDAs for Aspergillosis/Mucormycosis

11/21/2014

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 1/22/15, from 8 a.m. to 5 p.m. at the FDA W...

Guidance on Changes to Blood Product Application

11/21/2014

Federal Register Notice: FDA is making available a guidance document: Changes to an Approved Application: Biological Products: Hum...

FDA Corrects Notice on REMS

11/21/2014

Federal Register Notice: FDA is correcting a notice entitled “Report on the Standardization of Risk Evaluation and Mitigatio...

Workshop on Drug Development and Rare Subsets of Patients

11/21/2014

Federal Register Notice: FDA is announcing a public workshop 12/12 entitled “Developing and Using Precision Therapies in the...

Comments Sought on Supplement GMP Info

12/19/2013

Federal Register Notice: FDA is seeking public comment on the information collection provisions of FDA’s current good manufa...

Comments Sought on Tobacco Substantial Equivalence Requirements

12/19/2013

OMB OKs Info on Device ID

12/19/2013

Federal Register Notice: FDA’s collection of information entitled “Unique Device Identification System,” has bee...

OMB OKs Info on Cardiovascular Labeling

12/19/2013

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Hypertension Indication: D...

Info on Device Communications Sent to OMB

12/19/2013

Workshop on Endpoints on Intraocular Lenses

12/19/2013

Federal Register Notice: FDA will hold a public workshop 3/28/14 entitled “FDA/American Academy of Ophthalmology (AAO) Works...