This article was originally published in The Gray Sheet
Agency's Center for Devices and Radiological Health issues "Guidance Document for Vascular Prostheses 510(k) Submissions," developed "as a special control to support reclassification from Class III to Class II for vascular graft prostheses," Nov. 26. The center simultaneously issues "Guidance for Annuloplasty Rings 510(k) Submissions," also as a special control, and "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions," which supersedes the agency's Feb. 11, 1997 guidance on premarket notification for the same devices. Draft "Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery" is also available for comment on CDRH web site
You may also be interested in...
Will the second wave of coronavirus lockdown have the same impact on the European consumer health industry? Speaking exclusively to HBW Insight from Germany, Merz Consumer Care CEO Frank Baldauf thinks not. Recently investing in premium beard care brand Brooklyn Soap and launching its tetesept Formula range in the Netherlands, Merz's Baldauf suggest that there will be less panic buying this time round and the CHC supply chain will hold up under pressure.
After a strong first quarter, Japan’s Towa Pharmaceuticals saw stability in its domestic revenues but a drop in revenues from its overseas business in its financial second quarter. After launching a series of molecules in June 2020, the company has lined up 10 launches for December 2020 as well.
Pfizer has revealed launch plans for its Nyvepria pegfilgrastim biosimilar, shortly after receiving formal European Commission approval.