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The EMA is planning to focus on 13 separate initiatives for 2017, ranging from fully implementing its priority medicines review pathway to boosting international cooperation. Read More
The Senate health committee has scheduled its vote on the nomination of Scott Gottlieb to be the next commissioner of the FDA — for April 26. Read More
The FDA issued Targeted Medical Pharma a warning letter for failing to submit an IND application prior to beginning clinical investigations for a product the agency deemed to be a drug. Read More
A survey of the world’s largest pharmaceutical companies found that only four were prepared to commit to single-digit percentage increases of the prices of their products annually. Read More
Manufacturers and industry groups urged the FDA to develop guidance on its processes for assigning a lead center for the review of a combination product. Read More