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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
The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing Wednesday. Read More
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Read More
The FDA will have to staff up and hire new kinds of scientists to fully implement the provisions of the 21st Century Cures Act and the next generation of user fee agreements, according to FDA leadership. Read More