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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
The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). 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The draft guidance says source criteria will come from FDA staff, literature, and data from existing devices, but it makes no mention of input from healthcare professionals and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
Efforts by hospitals to improve cybersecurity for medical devices often run up against unsecured legacy systems and the patching necessary to resolve the security flaws often impede the device’s function. Read More
The new inspection program will supplement the authority’s existing inspections aimed at prevention and control of healthcare-associated infections. Read More
France’s National Agency for the Safety of Medicines (ANSM) is calling for more exhaustive clinical studies prior to CE marking of flow diverter stents that are implanted to treat intracranial aneurysms. Read More
The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes. Read More