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Regulatory Review Determined for Welireg

[ Price : $8.95]

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Peloton Therapeutics Welire...

Guide on Drug Supply Chain Security

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FDA issues a guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.

Getinge Recalls CardioHelp Emergency Drive

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Getinge recalls its CardioHelp Emergency Drive due to a possible blocking or impairment of its emergency crank.

FDA Withdraws Ciprofloxacin for Cystitis

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Federal Register notice: FDA withdraws approval of Bayers Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five relate...

Info Collection on OTC Drugs

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Federal Register notice: FDA sends to OMB an information collection revision entitled Time and Extent Applications (TEA) for Nonpr...

Cardinal Health Recalls Procedure Kits

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Cardinal Health recalls its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9...

First Sickel Cell Gene Therapies Approved

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The first two cell-based gene therapies for treating sickle cell disease in patients 12 years and older gain FDA approval Vertex ...

Novartis Reports Risk Reduction Kisqali Data

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Novartis reports updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial that confirms an earlier benefit seen at an inte...

Alpha Cognition NDA for Alzheimers Filed

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FDA accepts for review an Alpha Cognition NDA for ALPHA-1062 for treating mild-to-moderate Alzheimers disease.

Section 503B Compounding Enforcement Discretion

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FDA publishes a draft guidance with an interim enforcement discretion policy for some Section 503 drug compounding using bulk drug...