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Human Cell Violations Found at Manhattan Reproductive

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FDAs New York District Office warns Manhattan Reproductive Health about violations of regulations governing human cells, tissues, ...

FDA, CMS Agree to Extend Parallel Review Pilot

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FDA and CMS say they are extending for two years a Pilot Program for Parallel Review of Medical Products.

FDA Wont Order Xenical and Alli Off Market

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FDA denies a Public Citizen petition asking that it pull Rx and OTC orlistat from the market for safety reasons.

Panel to Discuss Northera, Zontivity, Xarelto

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Federal Register Notice: FDAs Cardiovascular and Renal Drugs Advisory Committee will meet 1/14-16/14 to discuss Chelsea Therapeuti...

FDA Proposes Changes for OTC Consumer Antiseptic Washes

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Federal Register Proposed rule: FDA proposes to amend a 1994 monograph to establish conditions under which OTC consumer antiseptic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Stanislaw R. Burzynski, Burzynski Research Institute, Green Planet, Manhattan Re...

A New FDA Wrinkle? Just Dont Approve Nasty Products

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Washington commentator Bob Steeves says FDA may be deliberately refusing to approve any new tobacco products, thereby choking off ...

FDA Raises Many Ampligen Concerns

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FDA tells the Arthritis Advisory Committee it has concerns about the efficacy and safety of Hemispherx Biopharmas Ampligen in trea...

Merck, GE to Collaborate on Alzheimers Candidate

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Merck and GE Healthcare collaborate on a clinical study and license and supply agreement to use GEs investigational PET imaging ag...

Comments Sought on Device Review Assessment

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Federal Register Notice: FDA seeks comments on the comprehensive assessment of the device submission review process.