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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 New Dietary Ingredient Safety Procedures

11/14/2014

Federal Register Notice: FDA is seeking public comment on the procedure by which a manufacturer or distributor of a new dietary in...

Comments Sought on Export Certificate Requirements

11/14/2014

Federal Register Notice: FDA is inviting public comment on information collection requirements imposed on firms that intend to exp...

Comments Sought on Rx DTC Ad Research

11/14/2014

Federal Register Notice: FDA seeks comments on research entitled, “Spousal Influence on Consumer Understanding of and Respon...

Blood Panel Agenda Changed

11/14/2014

Federal Register Notice: FDA is amending a 10/22 notice of the meeting of the Blood Products Advisory Committee to reflect a chang...

FDA Amends Regs on FOI Changes

11/14/2014

Federal Register Final rule: FDA is amending the agency’s regulations to change the Division of Freedom of Information&rsquo...

Comments Sought on Rx Drug Administrative Procedures

11/14/2014

Federal Register Notice: FDA is seeking comments on the information collection in the regulations in the Prescription Drug Marketi...