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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 ...

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...

FDAers Defend Flibanserin Approval

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FDA staffers describe the process the agency followed in first rejecting and then approving Sprouts flibanserin for treating femal...

CDRH Compliance Shifting the Way it Monitors Industry

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CDRH Office of Compliance (OC) acting director Sean Boyd says OC has several initiatives under way to shift the way it monitors or...

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 ...

New Ionic Liquid Regs Needed: Chemists

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Four chemists write online for Nature that FDA should develop a new regulatory framework to cover ionic liquid drugs.

FDA Withdraws Approval of NADAs/ANADAs

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Federal Register Notice: FDA withdraws approval of two NADAs/ANADAs that are no longer marketed.