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FDA Approves Bayer NADA for Cats

08/02/2007

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Bayer Health NADA for veterinary...

FDA to Award Agreement on Radiation Control

07/30/2007

Federal Register Notice: FDA intends to receive and consider applications for the award of a cooperative agreement in FY 2007 to p...

Comments Sought on Licensed Biologics Arrangements

07/23/2007

Comments Sought on Licensed Biologics Arrangements

07/23/2007

Federal Register Notice: FDA solicits comments on the proposed collection of information, Draft Guidance for Industry: Cooperative...

Panels to Discuss Bayer’s Trasylol

07/23/2007

Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Adv...

Guidance on Pulse Oximeters for 510(k)s

07/19/2007

Federal Register Notice: FDA is making available a draft guidance, Pulse Oximeters — Premarket Notification Submissions [510...

Guidance on Devices with Antimicrobials

07/19/2007

Federal Register Notice: FDA is making available a draft guidance, Premarket Notification (510(k)) Submissions for Medical Devices...

Info on Physician Survey Sent to OMB

07/19/2007

Federal Register Notice: FDA’s proposed collection of information, “FDA Survey of Physicians' Perceptions of the Impac...

Brethine Not Withdrawn For S&E

07/19/2007

Federal Register Notice: FDA determines that Brethine (terbutaline sulfate) injection was not withdrawn from sale for reasons of s...

Comments Sought on Harmonized Device Proposals

07/13/2007

Federal Register Notice: FDA is making available and requesting comments on several proposed and final documents that have been pr...