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The Association of Indian Medical Device Industry said Indian devicemakers were ready to comply with the new rules and they should be implemented as soon as possible. Read More
Medical product sponsors and researchers should work with electronic health record keepers to help improve clinical trial accuracy and efficiency, the FDA said in a new guidance. Read More
Stakeholders asked the FDA to clarify its proposal to expand the Abbreviated 510(k) program by allowing the use of performance criteria for demonstrating substantial equivalence. Read More
The agency said applicants should determine the biocompatibility of all parts in the biliary stent and the delivery system that touch the patient. Read More
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