FDA, CMS may partner on pre-market reviews
In an effort to shorten the time it takes for newly approved medical products to be covered by third-party payors and administered to patients, the FDA and the Centers for Medicare and Medicaid Services (CMS) are considering a joint plan for overlapping evaluations of pre-market medical products.
Under the proposed process, the FDA and CMS would conduct parallel and partially coordinated evaluations of prescription drugs, biologics and medical devices when voluntarily requested by producers.
The process could reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs), according to the agencies. The two agencies also suggested that these overlapping evaluations could boost falling investment in medical innovation by speeding up the implementation and coverage of new products and thereby accelerating the returns to investors.
The proposal also calls for a pilot program for the two agencies to concurrently review innovative medical procedures.
The FDA and CMS are currently opening up a docket to the public to solicit recommendations for procedures for parallel review, categories of eligible products, timing of the evaluations and other protocols.
Electronic comments can be submitted by Dec. 16 by clicking here.
Under the proposed process, the FDA and CMS would conduct parallel and partially coordinated evaluations of prescription drugs, biologics and medical devices when voluntarily requested by producers.
The process could reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs), according to the agencies. The two agencies also suggested that these overlapping evaluations could boost falling investment in medical innovation by speeding up the implementation and coverage of new products and thereby accelerating the returns to investors.
The proposal also calls for a pilot program for the two agencies to concurrently review innovative medical procedures.
The FDA and CMS are currently opening up a docket to the public to solicit recommendations for procedures for parallel review, categories of eligible products, timing of the evaluations and other protocols.
Electronic comments can be submitted by Dec. 16 by clicking here.