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Joint Panel Nixes Nektars Back Pain Drug

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An FDA joint advisory committee votes 27 to 0 to not recommend approval of Nektar Therapeutics oxycodegol for back pain.

FDA Updates List of Deemed BLAs

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FDA updates the list of biological products that will be deemed to be BLAs on 3/23 to include chemically synthesized polypeptides.

McDermott Will & Emery FDA 2019 Review

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A McDermott Will & Emery review of FDA activities in 2019 finds a slight decrease in overall enforcement activity as the agency co...

Lannett Cocaine Nasal Anesthetic Approved

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FDA approves a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), indicated for the introduction of local ane...

FDA Still Questions Durects Posimir

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FDA asks members of the Anesthetic and Analgesia Drug Products Advisory Committee to evaluate whether Durect has provided sufficie...

Machine Learning Increasingly Important to FDA

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FDA staffers discuss the future role of machine learning in drug development and regulation.

FDA Device Warning Letters May Increase: Keith

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CDRH associate director Erin Keith says the Center will be issuing more Warning Letters now that staff are getting used to an inte...

Cleveland Clinic 3D Airway Stents Cleared

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FDA clears a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea.

Expedited Review Doesnt Cut Development Time: Study

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Harvard Medical School researchers say it is difficult to determine whether FDA expedited drug review and approval programs have a...

BioCardia Deflectable Guide Catheter Cleared

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FDA clears a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System ...