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Info on Application Certifications Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information on a certification to accompany drug, biologic and devic...

Info on Accredited Persons Inspections Sent to OMB

[ Price : $8.95]

Federal Register Notice: FDA sends a proposed collection of information on inspection requests under the accredited persons progra...

Panel to Discuss Non-Standardized Allergen Extracts

[ Price : $8.95]

Federal Register Notice: FDAs Allergenic Products Advisory Committee will meet 10/25 to hear CBERs review of literature on the use...

Panel to Discuss Community-Acquired Bacterial Pneumonia

[ Price : $8.95]

Federal Register Notice: FDAs Anti-Infective Drugs will meet 11/3 to discuss clinical trial design for developing antibacterials t...

Panel to Discuss Antibacterials for Hospital-Acquired Pneumonia

[ Price : $8.95]

Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 11/4 to discuss clinical trial design for antibact...

Panel to Discuss Salix Xifaxan for IBS

[ Price : $8.95]

Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/16 to discuss the design of clinical trials e...

Panel to Discuss Serotonin Receptor 4 Agonists

[ Price : $8.95]

Federal Register Notice: FDAs Gastrointestinal Drugs Advisory Committee will meet 11/17 to provide recommendations to FDA on prema...

FDA Report on Treating Allergic Disease

[ Price : $8.95]

Federal Register Notice: FDA releases a report of scientific and medical literature and information on the use of non-standardized...

CDER Adds 2 Offices Under Office of Medical Policy

[ Price : $8.95]

Federal Register Notice: FDA reorganizes CDER by establishing two offices under the Office of Medical Policy: Office of Prescripti...

Amarin Submits NDA for Triglyceride Therapy

[ Price : $8.95]

Amarin files an NDA for AMR101 for treating patients with very high triglycerides.