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FDA Defines Device Remanufacturing

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FDA publishes a final guidance to clarify the distinctions between medical device remanufacturing and servicing.

FDA Leaders Financial Ties to Drug Industry Probed

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A BMJ investigation looks at the relationship between several FDA commissioners and the companies the agency regulates.

Exocel Bio Selling Unapproved Exosomes: FDA

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FDA says Exocel Bio in San Diego is marketing unapproved exosome products.

Vyaire Recalls Exercise Test Component

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Vyaire Medical recalls (Class 1) its Vyaire Twin Tube sample line 240 cm, Model Number V-707327, which is used in the companys Vyn...

RAPT Unblinding Data in Trials on Clinical Hold

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RAPT Therapeutics closes and unblinds two Phase 2 trials of zelnecirnon following FDA clinical holds due to liver failure in one p...

BIO on Collecting Race, Ethnicity Data

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BIO asks FDA to hold more discussions on a draft guidance on collecting racial and ethnicity data in clinical trials and studies.

Device Lawyers Urge SCOTUS to Hear Off-Label Appeal

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DuVal & Associates asks the Supreme Court to hear an appeal of a 1st Circuit Court of Appeals decision upholding the conviction of...

No More Opioid Enriched Enrollment Studies: Califf

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During a Senate Appropriations hearing, FDA commissioner Robert Califf tells lawmakers that the agency is advising against enriche...

BLA Accepted for Subcutaneous Opdivo

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FDA accepts for review a Bristol Myers Squibb BLA for a subcutaneous formulation of Opdivo (nivolumab) across all previously appro...

Tandem Diabetes Recalls Pump Mobile App

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Tandem Diabetes Care recalls its t:connect mobile app (version 2.7) on the Apple iOS platform that is used with the companys t:sli...