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  • Bill Looks to Establish Provisional Approval Framework for Some Products

    A new piece of legislation proposed in the House of Representatives would amend the Federal Food, Drug and Cosmetic Act (FDCA) to allow for the US Food and Drug Administration (FDA) to issue tentative approvals for products given fast track designation. The bill, H.R. 6288 - The Patient Choice Act of 2012 , is sponsored by Rep. Brian Bilbray (R-CA) and currently is co-sponsored by Reps. Dan Boren (R-OK), Morgan Griffith (R-VA), Duncan Hunter (R-CA) and Jean Schmidt ...
  • Bill Introduced to Speed Development and Review of Breakthrough Therapies

    A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new "breakthrough therapy" designation at the US Food and Drug Administration (FDA). The bill, To amend chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to expedite the development and review of breakthrough therapies , would amend the FD&C Act  to include pr...
  • New Bill Looks to Streamline Inspections

    A new bill introduced by Representative Brian Bilbray (R-CA) would rein in regulatory overlap by preventing states from "requiring duplicative inspections" of manufacturing plants. Bilbray's bill, the Science and Technology Regulatory Relief Act of 2012 (H.R. 4044) , prevents states from requiring US Food and Drug Administration-inspected manufacturers to undergo a state-sanctioned inspection. Exceptions are provided if the state receives complaints of unsafe produ...