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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...
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    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 ...
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    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...
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    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...
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    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...
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    FDA Review Times Steadily Decreasing, Report Finds

    Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...
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    Congressional Support for Priority Review Vouchers Presses On Despite FDA Qualms

    Almost a decade into the experiment of offering lucrative priority review vouchers (PRVs) to help speed the development of treatments for neglected tropical and pediatric diseases and it seems Congress’s love of the vouchers has only just begun. And although that love is sure to be a good sign for companies looking to make hefty profits off of the vouchers on the open market (selling for upwards of $350 million), it’s a bad sign for the US Food and Drug Administration (...
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    FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

    The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer. The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an upd...
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    Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

    The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program. The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office ...
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    More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

    In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics. Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug A...
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    FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness

    The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments affecting fewer than 200,000 people, more than half o...