Latex Labeling Rule's Application To IVDs To Be Delayed For 270 Days - FDA
This article was originally published in The Gray Sheet
FDA is denying a Health Industry Manufacturers Association petition asking the agency to stay the implementation of its final rule on the labeling of devices containing natural rubber as the reg applies to in vitro diagnostics.
You may also be interested in...
Policy experts predicted how the incoming Biden administration will handle health care issues at a recent Alliance for Health Policy webinar. Rachel Nuzum, VP of state and federal policy at The Commonwealth Fund, said telehealth could be a priority.
The China National Biotec Group has filed the first application in China for the broad use of a COVID-19 vaccine, days after the national regulatory agency released review guidelines for the conditional approval of such products.
More patent-related turbulence appears ahead for Novartis’s sacubitril/valsartan combination in India, with Torrent emerging as the new challenger. The companies are engaged in a legal battle and the Indian firm is also seeking a revocation of the patent on the star heart failure treatment.