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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 Investigator Responsibilities

05/10/2007

Federal Register Notice: FDA is making available a draft guidance for industry entitled Protecting the Rights, Safety, and Welfare...

Vaccines Panel Meeting Time is Changed

05/10/2007

Federal Register Notice: FDA is amending the 4/16 notice of a meeting of the Vaccines and Related Biological Products Advisory Com...

Panel to Discuss CryoCor PMA for Atrial Flutter

05/10/2007

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 6/27, fr...

Guidance on Computerized Systems Used in Trials

05/10/2007

Federal Register Notice: FDA is making available a guidance for industry entitled Computerized Systems Used in Clinical Investigat...

Panel to Discuss Neuroblastoma Treatment

05/08/2007

Federal Register Notice: FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will meet 6/27, fro...

Comment Period Extended on Hemostatic Device

05/08/2007

Federal Register Proposed rule: FDA is reopening until 6/7 the comment period for the proposed rule, published in the 10/31/06 Fed...