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Review Period Set for Noxafil

05/21/2007

Federal Register Notice: FDA has determined the regulatory review period for Schering Corp.’s Noxafil (posaconazole) is 3,65...

Review Period Set for Iressa

05/21/2007

Federal Register Notice: FDA has determined the regulatory review period for AstraZeneca’s Iressa is 1,967 days for extendin...

FDA Sets Review Period For Guidant Radiotherapy System

05/21/2007

Federal Register Notice: FDA has determined the regulatory review period for Guidant Corp.’s Galileo Intravascular Radiother...

Updated Recognized Standards List

05/21/2007

Federal Register Notice: FDA is releasing “Modifications to the List of Recognized Standards, Recognition List Number: 017&r...

Comments Sought on Submitting Info to Trial Data Banks

05/14/2007

Federal Register Notice: FDA is seeking public comment on the collection of information contained in the guidance Information Prog...

Guidance on Decorative/Non-corrective Contacts

11/27/2006

Federal Register Notice: FDA is making available a document entitled Guidance for Industry, FDA Staff, Eye Care Professionals, an...

Dispute Panel to Discuss Acorn Device

11/27/2006

Federal Register Notice: FDA’s Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee will meet...

Comments Sought on E-submissions to CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval on the existing repo...

Comments Sought on E-mailing a Study Protocol

11/08/2006

Federal Register Notice: FDA is seeking public comment on extending OMB approval of existing reporting requirements for the infor...

Comments Sought on Electronic Meetings Requests with CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval of existing reportin...