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Teva Pharmaceutical will get nearly a four-month jump on launching a generic version of BMS’ cancer drug Paraplatin now that the FTC has signed off on a deal between Bristol-Myers Squibb (BMS) and Teva.
The FTC’s May 24 advisory opinion, released last week, lets Teva start marketing the BMS-authorized product June 24.
The holding company for one of the country’s largest tobacco companies has come out in support of a bill introduced by a bipartisan group of powerful Washington lawmakers that would require the FDA to regulate tobacco products.
The number of adverse events reported to the FDA’s Center for Drug Evaluation and Research (CDER) increased 15 percent last year largely due to electronic filing of adverse event reports, according to the center’s chief.
The FDA has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications, while citing past lapses in the rules governing drug testing samples.
The FDA has accused an institutional review board (IRB) associated with Wright Medical of failing to report adverse events and using unsubstantiated clinical information in its premarket approval (PMA) applications.
The FDA has issued a warning letter to New York-based devicemaker TGM Products for failing to comply with numerous federal standards, including quality system regulations and documentation requirements.
Biotechnology firm Celsion revealed last week that it had received an FDA warning letter regarding violations in the Phase I and II trials of its Prolieve Thermodilatation system, which received marketing approval from the agency in February.
Results of the Taxus VI trial indicate that a higher-dose version of Boston Scientific’s paclitaxel-eluting stent is effective in preventing restenosis among high-risk patients, including diabetics.