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Scott Gottlieb has met with the chair of the Senate committee presiding over his confirmation as the next FDA commissioner, Sen. Lamar Alexander (R-Tenn.). Read More
The EMA’s Committee for Medicinal Products for Human Use is recommending EU approval of six drugs for treating a range of conditions from rare forms of cancer to chronic heart failure. Read More
The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic Research Labs’ facilities in India. Read More
The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) have not halted their investigation into the pricing of Emflaza, pursuing its sale from Marathon to PTC Therapeutics. Read More