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In a bipartisan 28-2 vote, the Senate Appropriations Committee Thursday approved the fiscal year 2016 appropriations bill to fund the FDA, but at levels far below what President Barack Obama had requested. Read More
Companies developing therapies that may have an adverse effect on the testes should conduct clinical trials to pin down the toxicity and whether it is reversible, the FDA says. Read More
As lawmakers work to draft a Senate version of the 21st Century Cures Act, indications are that it will be much smaller than the massive FDA overhaul bill passed by the House, with reforms focused on just a handful of issues. Read More
Strengthening and exploring additional uses of the FDA’s Sentinel System will be a top priority of PDUFA VI, agency officials said during a Wednesday public meeting to kick off negotiations on reauthorization of the Prescription Drug User Fee Act. Read More
The FDA and its European counterpart will establish a joint patient engagement working group to share best practices on involving patients in drug development and monitoring. Read More
The FDA has published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More