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Info on Cooperative Biologic Mfg. Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Draft Guidance for Industry: Cooperative Manufactu...

Info on Animal Drug User Fees Sent to OMB

11/19/2007

Federal Register Notice: FDA’s proposed collection of information, “Animal Drug User Fees and Fee Waivers and Reductio...

Info on CGMP for Medicated Feeds Sent to OMB

11/19/2007

Federal Register Notice: FDA is announcing that a proposed collection of information, “Current Good Manufacturing Practice R...

Guidance on Drug Development for COPD

11/09/2007

Federal Register Notice: FDA is making available a draft guidance for industry, Chronic Obstructive Pulmonary Disease: Developing ...

CBER PMAs Listed

11/09/2007

Federal Register Notice: FDA is publishing a list of PMAs that have been approved by CBER to inform the public of the availability...

Panel to Discuss Permanent Sterilization Method

11/09/2007

Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet 1...

Comments Sought on Device Fellowship Program

11/09/2007

Federal Register Notice: FDA solicits comments on the application for participation in the Medical Device Fellowship Program (MDFP...

Info on Orphan Products Sent to OMB

11/09/2007

Federal Register Notice: FDA’s proposed collection of information on the joint adoption by the agency and the European Medic...

Blood Regulations Updated

11/08/2007

Federal Register Proposed rule: FDA proposes to revise and update the regulations applicable to blood and blood components, includ...

Public Meeting Slated on Epinephrine MDIs

11/08/2007

Federal Register Proposed rule: FDA will hold a public meeting 12/5 to solicit comments on a 9/20 proposed rule that would amend F...