BOSTON – The FDA's Center for Device and Radiological Health (CDRH) released draft guidance on Monday aimed at encouraging the use of patient input in medical device clinical trials and helping sponsors understand how they can use patient engagement to improve the design and conduct of investigations.
BOGOTA, Colombia – Last month, Anvisa, Brazil´s health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant?
The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually.