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FDA Sends Info on Xenotransplantation to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the PHS guideline on infectious disease issues in xen...

Radiological Panel Backs Expanded Breast Screening Use

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FDAs Radiological Devices Panel votes 9 to 1 to recommend the approval of a Hologic PMA supplement to expand the use for its Selen...

Class 1 Recall for Stryker Neptune Waste System

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FDA classifies as a Class 1 recall a Stryker warning to healthcare providers about potential serious injuries to surgical patients...

FDA-483 from Compounding Firm Cites Microbial Contamination

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FDAs inspection of the pharmacy compounding operation at the center of the deadly meningitis outbreak cites significant microbiolo...

Ethicon Class 1 Recall of Surgical Staple Devices

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FDA says Ethicon has initiated a Class 1 recall of three surgical stapler devices because users have had difficulty firing the dev...

Tevas Synribo Approved for Leukemia

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FDA approves approveds a Teva Pharmaceuticals NDA for Synribo (omacetaxine mepesuccinate) to treat adults with chronic myelogenous...

FDA Denies Dispute Resolution on Watsons Prochieve

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FDA denies a Watson Pharmaceuticals formal dispute resolution request related to its pending NDA for Prochieve (progesterone vagin...

FDA Clears Medtronic Pediatric Cardiopulmonary Bypass

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FDA clears Medtronics Affinity Pixie Oxygenation System for cardiopulmonary bypass surgeries in neonates, infants and small childr...

Boehringer Agrees to Pay $95 Million Over Drug Marketing

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Boehringer Ingelheim Pharmaceuticals agrees to pay $95 million to the U.S. government to resolve allegations relating to improper ...

FDA Heeds Court Order, Approves Watson ANDA

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FDA complies with a federal court order and approves Watson Pharmaceuticals generic version of Actos (pioglitazone hydrochloride) ...