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FDA Explores 'Mechanism' for Reporting Drug Shortages

[ Price : $8.95]

FDA examines developing a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which c...

FDA 'Orphan' Status for Hodgkin's Drug

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FDA grants 4SC AG an orphan drug designation for its lead oncology compound resminostat in Hodgkin's lymphoma.

Info on Application Certifications Sent to OMB

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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

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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

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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

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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

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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

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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

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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

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