Colorado BioScience Association (CBSA) and our national partners support the critically important reauthorization of the U.S. Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements and updates to the Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act.
In a 13-9 vote, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The act reauthorizes most of FDA’s user fee programs and includes major provisions, such as Certificates to Foreign Governments (CFGs) and predetermined change control plans (PCCP). The legislation also encompasses the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which would give FDA additional authorities to regulate in vitro diagnostics (IVD), including laboratory-developed tests (LDTs).
If passed by the Senate, this version of the bill would have to be reconciled in conference with the user fee authorization bill, H.R. 7667, the Food &…
Click here to view original post
