Biosil saline breast implant 510(k) on hold due to GMP deficiencies -- FDA warning letter.
This article was originally published in The Gray Sheet
Executive Summary
BIOSIL GMP PROBLEMS STALLING 510(k) FOR SALINE-FILLED BREAST IMPLANTS, FDA tells the firm in a Dec. 24 warning letter. FDA says that it will not clear Biosil's 510(k) for a saline-filled breast implant until the company corrects good manufacturing practices violations observed at its Cumbernauld, Scotland facility during a pre-clearance inspection for the submission. The agency says that a reinspection of the facility will be needed to verify the corrections.
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.