FDA Defends Its Line Of Communication As Lifecore Revamps MDR Procedures
This article was originally published in The Gray Sheet
Executive SummaryLifecore Biomedical had sufficient opportunity to obtain FDA guidance on medical device reporting (MDR) for theIntergel adhesion prevention solution, despite the firm's claims to the contrary, the agency maintains in a Dec. 1 letter
You may also be interested in...
After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.
South Korea’s HLB has begun a new growth phase by taking over US-based clinical stage biotech firm Immunomic Therapeutics. Through the acquisition, it is poised to add new pipeline assets including a Phase II vaccine therapy for glioblastoma and proprietary lysosomal targeting technology.