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  • Regulatory NewsRegulatory News

    Updated: House and Senate Pass Tax Overhaul

    The US House of Representatives and the Senate on Wednesday passed the GOP tax overhaul bill. President Donald Trump indicated he will sign the bill into a law. Bill Details Members of the House-Senate Conference Committee on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half . The cut would reduce the credits claimed by companies by $32.5 billion from 2018 to 2027, according t...
  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Amgen’s Humira Biosimilar

    The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab). The vote – 26-0, with no abstentions – followed the release of a positive review from FDA staff, and came after a lot of discussion on whether the data presented by Amgen could be extrapolated to all of the indications that Humira is approved for, as well as questions on analytical ch...
  • Regulatory NewsRegulatory News

    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
  • Senate Passes FDA User Fee Legislation, Bill Now Moves to White House

    In an expected development, the US Senate on Tuesday (26 June) voted overwhelmingly to approve the Food and Drug Administration Safety and Innovation Act (FDASIA) , advancing the bill to the White House where it is expected to receive approval from President Barack Obama in July. The 92-4 vote followed months of negotiating between the House of Representatives, the Senate, the US Food and Drug Administration (FDA), the pharmaceutical industry, the medical device i...
  • FDA User Fee Bill Easily Passes the House, On Pace for July Approval

    • 21 June 2012
    • By
    The Food and Drug Administration Safety and Innovation Act (FDASIA) is set to be voted on in the Senate next week after receiving overwhelming approval from legislators in the US House of Representatives on 20 June. The user fee legislation would reauthorize and make changes to a number of existing programs that provide industry funding for activities at the US Food and Drug Administration (FDA), as well as make a litany of changes at the agency. FDASIA is among the...
  • House to Vote Wednesday on FDA User Fee Legislation

    • 20 June 2012
    • By
    The US House of Representatives is preparing to vote on a piece of user fee legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) as early as Wednesday, 20 June, reports The Hill . The bill, which would provide the US Food and Drug Administration (FDA) funding and make numerous regulatory reforms to the agency, had earlier passed both the Senate and House of Representatives in May 2012. The bill has since been before congressiona...
  • Congress Releases Final Version of User Fee Bill, Shedding Controversial Provisions

    Congressional negotiators have succeeded in merging together two largely similar user fee bills aimed at providing funding and reforms for the US Food and Drug Administration (FDA), leaving out many of the bill's most controversial provisions. In a statement posted late on 18 June 2012, House Energy and Commerce Committee members said the merged bill, called the Food and Drug Administration Safety and Innovation Act (FDASIA) , proves members of Congress can still wo...
  • House Overwhelmingly Passes User Fee Legislation

    • 31 May 2012
    • By
    The House of Representatives voted overwhelmingly to support the Food and Drug Administration Reform Act (FDARA) , sending the bill to a conference committee for an ultimate merger with the Senate's  Food and Drug Administration Safety and Innovation Act (FDASIA) . House members voted 387 to 5 in support of the legislation, which would institute a package of reforms to the US Food and Drug Administration (FDA) and renew and create a series of industry-paid user fee...
  • House to Vote on User Fee Reauthorization, Medical Device Tax Repeal Bills

    The US House of Representatives is moving quickly to vote on a package of reforms and user fee proposals similar to one approved on 24 May by the US Senate, with House leadership confirming a bill containing the provisions will be brought to a vote on 30 May. The bill, the Food and Drug Administration Reform Act (FDARA) , would renew and expand user fee provisions required of industry and used to fund the US Food and Drug Administration (FDA), which would also see a n...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...
  • User Fee Bill Advances to Vote in Senate

    The Food and Drug Administration Safety and Innovation Act (FDASIA) , the Senate's iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving the legislation one step closer to passage. On 21 May, a " motion to proceed to consideration of measure ," was passed, allowing the bill to advance for final debate and markup. A final vote on FDASIA is expected to occur between 23-25 May. The legislation was delayed ...
  • User Fee Bill Appears Ready to Pass House Subcommittee

    The US House of Representatives' Energy and Commerce Subcommittee on Health meets 8 May to conduct its markup process for various user fee bills, including the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA) . The markup process has already seen an enormous amount of activity and some surprising developments. Regulatory Focus summarizes those developments for you here: The House Energy and Commerce Committee Subcommittee on Healt...