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GCP Workshop Considerations

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Discussions from a joint FDA-MHRA workshop on good clinical practice are published by the American Society for Clinical Pharmacolo...

No PMA, IDE for Draegar Systems

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FDA warns Draegar Medical about manufacturing medical devices without an approved PMA or IDE and with Quality System violations.

FDA Says Galemed Babi.Plus Recall Class 1

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FDA says the Teleflex recall of the Glaemed Babi.Plus 12.5 cm pressure relief manifold is Class 1.

Triple Combination Drug Approved for Diabetes

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FDA approves Boehringer Ingelheim Pharmaceuticals and Eli Lillys Trijardy XR (empagliflozin/linagliptin/metformin HCl) to lower bl...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Baja Fur, Dental-Kosmetik, Draegar Medical Systems and Sunstar Guan...

DTC Study on Ad Endorser Influence

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Federal Register notice: FDA seeks comments on a proposed study entitled Endorser Status and Explicitness of Payment in Direct-to-...

Guide on Arthroscopy Pump Tubing Sets

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Federal Register notice: FDA makes available a draft guidance entitled Arthroscopy Pump Tubing Sets Intended for Multiple Patient ...

FDA Issues Gene Therapy Guidances

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FDA releases six final and one draft guidance to further gene therapy product development.

Athenex Pharma Solutions FDA-483

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FDA releases the FDA-483 with four observations from an inspection at the Athenex Pharma Solutions outsourcing facility.

FDA Adds Medline to List of Closed Device Sterilizers

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FDA says Medline Industries ethylene oxide medical device sterilization facility in Waukegan, IL, has been voluntarily closed sinc...