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President Trump announced his intention to nominate Hahn as the agency’s leadership role on Nov. 1, and the nomination was officially sent to the Senate. Read More
An FDA advisory committee voted unanimously on Thursday to recommend approval of Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events in adults. Read More
An HHS proposed rule currently under review at the Office of Management and Budget would have the U.S. pay less than other developed countries for some Medicare drugs by using a “most favored nation” approach, HHS Secretary Alex Azar said Wednesday. Read More
CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in Oct. 30 remarks to a House subcommittee. Read More
The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Read More
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More
The physician previously pled guilty to 14 counts of illegal distribution of controlled substances in a related criminal case and is expected to be sentenced in January 2020.
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The DEA said that 27 percent of sampled tablets it seized nationwide between January and March 2019 contained potentially lethal doses of fentanyl. Read More