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U.S. lawmakers want the FDA to explain who regulates the 28,000 compounding pharmacies operating in the country and how the agency can better control them.
The Supreme Court has left intact existing precedents that allow OTC-drug makers to be sued for failing to place warnings on their products that are more robust than the OTC monograph requires.
The European Medicines Agency (EMA) is advising sponsors to use placebo arms, rather than active comparators, in short-term trials of schizophrenia drugs, according to a final guidance.
Avanir Pharmaceuticals is initiating a second lawsuit against Impax Laboratories, alleging Impax’s ANDA for generic Nuedexta infringes on a new Avanir patent.
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