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  • 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 This finalization of the 2008 draft guidance includes 25 questions and answers and includes the following substantive changes based on pu...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...
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    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

    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...
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    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 ...
  • Regulatory NewsRegulatory News

    House Looks to Reform Tropical Disease Priority Review Voucher Program

    The House Energy and Commerce Committee on Wednesday passed by voice vote an amendment (to an unrelated bill on hospital preparedness for dangerous threats) that would significantly change the priority review voucher (PRV) program for tropical diseases. Background Since 2009, the US Food and Drug Administration (FDA) has issued nine PRVs to reward companies for developing new drugs to treat rare pediatric and tropical diseases with a voucher that can be sold on the op...
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    Researchers Urge Caution on Expanding Priority Review Voucher Programs

    As Congress looks to further expand current priority review voucher (PRV) programs (and even create entirely new ones), researchers are now cautioning that the worth of the vouchers could decline significantly and diminish incentives to develop drugs for neglected diseases. Background Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers to pharmaceutical and biotech companies developing drugs and biologics fo...
  • Regulatory NewsRegulatory News

    Coalition Calls on FDA to Follow EMA’s Lead and Offer Scientific Opinions on Use of Drugs Outside US

    As part of efforts to streamline and strengthen regulatory pathways for global health products, the Global Health Technologies Coalition (GHTC) says in a new report issued Thursday that Congress should direct the US Food and Drug Administration (FDA) to establish a specific mechanism to offer a formal scientific opinion on medical products for their use outside the US. Because FDA is classified as a stringent regulatory authority, the agency’s review of drugs and devices...
  • Regulatory NewsRegulatory News

    EMA Assesses Concerns With Indian Generic Firm’s Clinical Data

    The European Medicines Agency (EMA) has begun a review of medicines for which studies have been conducted at Alkem Laboratories’s site in Taloja, India due to data integrity concerns. The review follows a joint good clinical practice (GCP) inspection of this site by German and Dutch regulators in March 2015, which raised issues with study data used to support the marketing authorization applications of some medicines in the EU. Following consideration of the inspectio...