Protocol Deviations Prompt 483s for Clinical Investigators
Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Source: Drug Industry Daily
FDA Pulls Luveris NDA at Company’s Request
The FDA has withdrawn the NDA for injectable fertility drug Luveris at the request of the manufacturer. Source: Drug Industry Daily
KaloBios Announces New Transparency Measures for Drug Prices
Although it has no drugs on the market, KaloBios Pharmaceuticals has announced that it will limit price increases to the rate of inflation or Consumer Price Index, and will do…
AbbVie, Genentech Scoop Up FDA Approval for Leukemia Drug Venclexta
The FDA has given the green light to the chronic lymphocytic leukemia treatment Venclexta, which will be marketed by AbbVie and Roche’s Genentech unit. Source: Drug Industry Daily
Senate Committee Eyes Contempt Proceedings Against Valeant’s Pearson
Two lawmakers are mulling contempt proceedings against outgoing Valeant CEO J. Michael Pearson after he failed to provide a deposition on Friday as part of an investigation into drug pricing.…
FDA: Consider Real-World Usage Early On To Avoid Medication Errors
The FDA is pressing drugmakers to build risk assessments into their drug designs early on to cut down on medication errors. Source: Drug Industry Daily
FDA Adds Three Chinese Drugmakers to Import Alert Lists
The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection. Source:…
Senator Criticizes FDA for Approach to Oxilofrine in Supplements
Sen. Claire McCaskill (D-Mo.) is taking the FDA to task for its delayed reaction in targeting companies marketing supplements containing oxilofrine, a stimulant banned by the World Anti-Doping Agency for…
FDA Adcomm Votes Unanimously to Recommend Intercept’s Obeticholic Acid
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated…
Full Issue of Drug Industry Daily
View the entire issue. Source: Drug Industry Daily