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Mylan Paying $465 Million to Resolve EpiPen Claims

[ Price : $8.95]

The Justice Department says Mylan is paying $465 million to resolve a Sanofi-Aventis whistleblower suit alleging that it knowingly...

FDA Makes Plasma Samples Available for Zika Tests

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FDA says it is making a panel of human plasma samples available to help in evaluation of serological tests to detect recent Zika v...

Organs-on-a-Chip Could Change Drug Testing

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A CNBC report looks at the emerging biotech science of creating organs-on-a-chip that mimic key functions of organs in the body an...

Wyeths Cordarone Not Withdrawn Due to Safety/Effectiveness

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FDA determines that Wyeth Pharmaceuticals Cordarone (amiodarone hydrochloride) tablets, 200 mg, were not withdrawn from sale for r...

Joint Advisory Committee to Review Purdue Opioid Pain Drug

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Federal Register notice: A 9/14 joint advisory committee plans to review a Purdue Pharma supplemental NDA new for Butrans (bupreno...

Questions Raised About FDA Approval Studies

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Researchers question the value of clinical trials and the data they produce as used by FDA to grant accelerated approval to drugs ...

Making NDA/BLA Development Meetings Better: Parexel

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Parexel executives say new drug sponsors could benefit from using an advantages/disadvantages matrix to prepare for a presubmissio...

Questions on New FDA Digital Health Approach

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Health Affairs bloggers say FDAs new digital health approach raises as many questions as it answers.

FDA Clears Strykers Serrato Pedicle Screw

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FDA clears a Stryker 510(k) for the Serrato Pedicle Screw, intended for use in the non-cervical spine as part of the companys Xia ...

Seattle Genetics sBLA for Adcetris

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FDA accepts for priority review a Seattle Genetics supplemental BLA for Adcetris (brentuximab vedotin) for use in patients with cu...