Chart: Grassley Wants Update On 510(k) Modifications Guidance
This article was originally published in The Gray Sheet
Executive SummarySen. Chuck Grassley, R-Iowa, wants a status report on FDA's revised guidelines for helping firms decide whether or not to submit a new 510(k) after making changes to an already cleared device, according to a Feb. 16 letter to FDA Commissioner Margaret Hamburg.
You may also be interested in...
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.