Chart: The (New) Anatomy Of A 510(k)
This article was originally published in The Gray Sheet
You may also be interested in...
FDA Maps Out Potential 510(k) Reforms In Long-Awaited Report
FDA released its highly anticipated proposals for reforming the 510(k) program last week, and industry reps acknowledged that many of the individual recommendations could benefit companies
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.
Quotable: Words Of Wisdom From Our Recent APAC Coverage
Scrip's APAC team selects notable quotes from recent interviews, conferences and other coverage to highlight the views of senior executives and officials on the major topics facing the biopharma sector in the region.