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United Therapeutics submitted four similar petitions since 2016 regarding ANDAs that reference Tyvaso, but the agency denied all four on the grounds that it had not made a final decision on any applications that would be affected. Read More
On July 10, after China responded with its own tariffs on U.S. imports, the administration doubled down, proposing additional tariffs on another 6,000 Chinese products worth $200 billion. Read More
The government is currently working with the European Commission to examine how to extend current CE mark RED requirements to minimum requirements for the digital safety of wireless devices. Read More
The draft guidance says source criteria will come from FDA staff, literature, and data from existing devices, but it makes no mention of input from healthcare professionals and other stakeholders. Read More