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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Alternative Health Approaches, Dialysis Dimensions, EM Probe, and Washington Hos...

FDA Approves New BMS Breast Cancer Drug

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FDA approves BMS new chemotherapy drug Ixempra (ixabepilone) to treat advanced breast cancer in women whose tumors are resistant t...

FDA Has Limited Say in Reagan-Udall Focus: Woodcock

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CDER acting director Janet Woodcock confirms to the Associated Press that the agency will have a limited say in what direction the...

Judge Rejects FDA Pleas on its Vioxx FOI Performance

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A New Jersey federal judge rejects FDA arguments defending its failure to adequately respond to three years of FOI requests from a...

Medi-Promotions Launches New Rx Pad

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Medi-Promotions launches its Medi-Scripts Plus prescription pad that included advertiser patient offers such as coupons and vouche...

FDA OKs Velcades Expanded Use

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FDA approves an expanded use for Millennium Pharmaceuticalss Velcade for treating multiple myeloma in patients with impaired kidne...

FDA Extends Tysabri Review on Crohns Indication

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FDA extends by three months its review of an Elan and Biogen Idec BLA on Tysabri (natalizumab) as a treatment for Crohn's disease.

Guidance on Noninferiority Studies for Antibacterials

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Federal Register Notice: FDA releases a draft guidance on use of noinferiority studies to support approval of antibacterial drug p...

Guidance on Dietary Supplements AERS

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Federal Register Notice: FDA releases a draft guidance on adverse event reporting and recordkeeping for dietary supplements as req...

Guidance on OTC Postmarketing AERs

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Federal Register Notice: FDA releases a draft guidance on postmarketing adverse event reporting for nonprescription human drugs ma...