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Review Period Set for Bayer Animal Healths Veraflox

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Federal Register Notice: FDA determines the regulatory review period for Bayer Animal Healths Veraflox for the purpose of patent e...

Justice Official: Money Penalties Not Enough in Settlements

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Justice Department official says the days of a money-only penalty in corporate criminal settlements is long over and company offic...

9,469 Malfunctions in Tests Califf Oversaw: Public Citizen

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Public Citizen says its analysis of FDA records shows many reports of INRatio injuries and malfunctions in patients before a clini...

FDA Priority Review for Pfizer Ibrance sNDA

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FDA accepts for priority review a Pfizer supplemental NDA for its breast cancer medication, Ibrance (palbociclib) for an expanded ...

Conflicting Morcellator Research

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An online study sets the rate of leiomyosarcoma among women undergoing morcellation at 1 of 429 per 1,000 hysterectomies, riskier ...

Comments Sought on Enhanced Transparency Submissions

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Federal Register Notice: FDA seeks comments on a proposed collection of information on interviews of pharmaceutical manufacturers ...

Review Period Set for Eliquis

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Federal Register Notice: FDA determines the regulatory review period for Bristol-Myers Squibbs Eliquis for the purpose of patent e...

FDA Panel Backs Teva Asthma Drug in Adults

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An FDA advisory committee votes 11 to 3 to recommend approval of a Teva Pharmaceutical Industries BLA for Cinqair (reslizumab) for...

Hearing Mulls Priority Review for Generics to Curb Prices

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Johns Hopkins Bloomberg School of Public Health professor Gerard Anderson tells a Senate hearing that Congress should consider cre...

Wording Changes Help Risk Info Comprehension: Study

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An FDA-funded study demonstrates that consumers gain a better understanding of drug safety risk communications when they follow pl...