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Panel to Discuss Pneumococcal, H1N1 Vaccines

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Federal Register Notice: FDAs Vaccine and Related Biological Products Advisory Committee will meet 11/18

Anaphylactic Reaction Risk with Dexferrum

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American Regent says Dexferrum prescribing information has been revised to emphasize concerns about anaphylactic-type reactions an...

FDA OKs Ortho HIV Assay

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FDA approves Ortho Clinical Diagnostics diagnostic assay for detecting antibodies to human immunodeficiency virus (HIV) types 1 an...

CBER Sees False, Misleading Info in Carticel Sales Materials

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CBER says a Genzyme sales aid and patient biopsy letters for Carticel overstate its efficacy and make unsubstantiated comparative ...

Questcor Re-files sNDA for H.P. Acthar Gel

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Questcor resubmits a supplemental NDA for H.P. Acthar Gel (repository corticotrophin injection) for treating infantile spasms.

Latest FDA Inspection Documents Posted

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FDA Webview posts to its Web site the latest FDA inspection documents we have received pursuant to our FOIA requests, for Advanced...

FDA Approves New Vaccine for Preventing Cervical Cancer

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FDA approved GlaxoSmithKline Biologicals new vaccine Cervarix to prevent cervical cancer and precancerous lesions caused by HPV Ty...

Guidance Defines Established Pharmacologic Class

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FDA publishes a guidance on determining the established pharmacologic class to be shown in labeling for prescription drugs and bio...

FDA Approves GSKs Cervarix

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FDA approves GlaxoSmithKlines Cervarix indicated for preventing cervical pre-cancers associated with HPV types 16 and 18 in female...

Pediatric Crestor Use Approved by FDA

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FDA approves AstraZenecas Crestor (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hyper...