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Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere. Read More
A bipartisan appropriations bill for fiscal 2019 that would give the FDA $269 million more than in fiscal 2018 passed in the Senate and House on Thursday and is expected to be signed into law by the president. Read More
Members of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb on Wednesday calling for a briefing on the ongoing recalls of sartan blood pressure drugs and on the agency’s foreign inspections. Read More
The FDA is seeking participants for a pilot program to help the agency define specific established conditions (ECs) for chemistry, manufacturing and controls in applications for NDAs, ANDAs and BLAs. Read More
Drug sponsors are eager for the FDA to embrace real-world evidence, but several companies are asking the agency to clarify how it can be used in clinical trials. Read More
Congressional Democrats are calling on the FDA to answer “substantive questions” surrounding the agency’s approval of Dsuvia, AcelRx’s sublingual formulation of the powerful opioid sufentanil. Read More