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House Speaker Nancy Pelosi announced yesterday that drug pricing measure H.R. 3 is headed to a House floor vote next week, where it is expected to pass. But because there is no Senate companion measure, there is unlikely to be final legislation on drug pricing this year. Read More
Most of the new draft guidances are aimed at oral formulations, while most of the revised guidances are aimed at topical and transdermal formulations. Read More
The FDA previously granted accelerated approval under Project Orbis for Eisai’s Lenvima in combination with Keytruda for certain patients with advanced endometrial cancer. Read More
The White House Council of Economic Advisers yesterday joined in the debate over the impact of H.R. 3, a drug pricing bill currently awaiting a vote on the House floor. Read More
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released draft advice for GMP inspectors on evaluating risk-based changes to pharmaceutical quality systems (PQSs). Read More