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  • Regulatory NewsRegulatory News

    EMA Prioritizes Three New Treatments as Part of its PRIME Scheme

    The European Medicines Agency (EMA) on Wednesday announced that it recently granted eligibility to three new treatments as part of its PRIME scheme, which focuses on medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. The newly added medicines, which are considered priority medicines by EMA, include Cymabay Therapeutics’ MBX-8025 , which is intended to treat Primary Biliary Cholangitis, a ch...
  • Feature ArticlesFeature Articles

    Global Regulatory Strategy

    This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers. The term "strategy," per Merriam Webster (Edition 11), means "a careful plan or method for achi...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Tropical Disease PRVs, Offering a Number of Clarifications

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on tropical disease priority review vouchers (PRVs), clarifying when a voucher can be used, whether drugmakers are “guaranteed” a six-month review when using a voucher and whether FDA can remove a tropical disease from the list of considered diseases (it can’t). This finalization of the 2008 draft guidance includes 25 questions and answers and includes the following substantive changes based on pu...
  • Regulatory NewsRegulatory News

    Priority Review Voucher Fees to Decline in FY 2017

    The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year. Tropical Disease Priority Review Voucher User Fee Year Voucher Fee FY 2011 $4,582,000 FY 2012 $5,280,000 FY 2013 $3...
  • Regulatory NewsRegulatory News

    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
  • Regulatory NewsRegulatory News

    Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

    Congress and President Barack Obama have one week to reauthorize the rare pediatric priority review voucher (PRV) program or else it will end on 30 September 2016, after seven pediatric PRVs have been awarded, one of which sold for $350 million last year. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments, affecting fewer than 200,000 patients under the age of 18. The vouchers can be used to speed FDA’s review ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia Moves Closer to Establishing Expedited Reviews Australia has pushed its expedited review program closer to fruition by accepting the recommendations of an expert panel, which called for the creation of an expedited review pathway and an option to leverage overseas approvals when trying to bring a drug to market in Australia. Lloyd Sansom, Will Delaat and John H...
  • Regulatory NewsRegulatory News

    Authorized Generics: Why Mylan Would Compete With Itself in the EpiPen Market

    As part of an attempt to quell the furor over its more than 400% price increase for its life-saving EpiPen, Mylan announced on Monday that it would soon launch an authorized generic version of its autoinjector for half the price of the brand-name product. The identical generic two-pack of EpiPens, expected to launch in several weeks , will have a list price of $300, which is half the list price of the brand product, but still significantly more than the price was prior...
  • Regulatory NewsRegulatory News

    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...
  • Regulatory NewsRegulatory News

    EMA Adds Four New Drugs to PRIME Scheme

    The European Medicines Agency (EMA) has granted four new drugs eligibility to its PRIority MEdicines (PRIME) scheme, bringing the total number of drugs accepted to the program to eight. Like the US Food and Drug Administration's (FDA) breakthrough therapy program, PRIME aims to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors in order to facilitate an accelerated product assessme...
  • Regulatory NewsRegulatory News

    House E&C Committee Clears New Priority Review Voucher Program

    The House Energy & Commerce Committee late Wednesday pushed through a bill that will create a new priority review voucher (PRV) program for medical countermeasures that will not sunset. The new PRVs for medical countermeasures, if passed by the full House and Senate, would be the third PRV program in existence (in addition to the rare pediatric disease and neglected tropical disease PRV programs ) and the first to not sunset. Like the other two PRV programs, HR 3299...
  • Regulatory NewsRegulatory News

    NIH Finalizes Single IRB Policy to Reduce Redundancies

    The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year. NIH made the announcement in a notice published to the Federal Register , saying its goal is to "enhance and streamline the IRB review process" for multi-site clinical trials. Overall, NIH says feedback on the policy was supportive, though some commenters felt the ...