Anyone see OVAS today on their 361 issue? Wedbush has a note on it and mentions MDXG. "FDA sent a similar "untitled" letter to MDXG last week and their path forward remains murky. MDXG, a tissue based wound healing company received an untitled letter from the FDA on 9/4/13 questioning the company's micronized injectable products...eligibility under 361 HCT/P. The MDXG letter, much like the OVAS letter, did not specify the basis for the FDA's conclusion and singled out MDXG even though multiple players process similar tissue based products (bone, dermis, fascia)
It's not just the FDA. CMS is using new proposals left and right (finding savings in Medicare to fund Obamacare). The OIG is investigating waste, fraud and abuse more than ever. Unfortunately the savings aren't being used to preserve Medicare itself. Many of us feel we are in Healthcare 2.0.
sounds like the fda is changing the rules after the game started. Maybe its job security, the government seems to be excellent at this. Find problems where they don't exist just so they can prove that they are doing something. Instead of sequestering the ATC system they should have cut some of the FDA.
Something to think about. Which agency stands to benefit if companies will be required to raise capital to fund trials? Lets not forget that government is also in the business of business. What is in all of those 5,000 pages of the health reform bill?
There was definitely CYOA at FDA after the Vioxx fiasco. Some will argue that FDA has historically been understaffed as well.