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  • Regulatory NewsRegulatory News

    FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

    The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug. Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic dr...
  • Regulatory NewsRegulatory News

    Priority Generic Drug Reviews: New FDA Draft Guidance

    In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II) , the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs. Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their a...
  • Regulatory NewsRegulatory News

    EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

    The European Medicines Agency (EMA) on Wednesday announced that it has accepted five additional therapies to its PRIME (PRIority MEdicines) scheme, bringing the total number of products accepted to the program to 25. The agency also said it denied seven requests for eligibility, which seeks to streamline the development of promising new therapies through earlier scientific advice and increased engagement between EMA and sponsors. While this latest batch of recomme...
  • Regulatory NewsRegulatory News

    FDA Approves First Treatment for a Form of Batten Disease

    The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV). FDA approved Brineura (cerliponase alfa) to slow the loss of walking ability in symptomatic pediatric patients three years old and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency. ...
  • Regulatory NewsRegulatory News

    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...
  • Regulatory NewsRegulatory News

    Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees

    With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022. Forged via negotiations between FDA and the various industries dating back to 2015, and racing to beat a September deadline, the bills sequentially increase the amount of user fees FDA can assess for r...
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    FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval

    A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market. Unlike standard reviews, which can take up to ten months, drugs that treat serious conditions or offer a significant improvement over existing treatments can qualify for a shorter, six-month review. However, the authors note that because drugs given priority rev...
  • Regulatory NewsRegulatory News

    Sarepta Sells Priority Review Voucher for $125M to Gilead

    Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months. The voucher was awarded to Sarepta under the rare pediatric PRV program after winning FDA approval for its Duchenne Muscular Dystrophy (DMD) drug Exondys 51 (eteplirsen) in September 2016. This is the third PRV Gilead ...
  • Regulatory NewsRegulatory News

    2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning

    Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June). On the positive side: Agreements on the reauthorizations for each of the user fee bills that will help fund FDA for the next...
  • Regulatory NewsRegulatory News

    Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways

    As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways. TGA’s priority review pathway, like Health Canada’s and FDA's  pathway with the same name , will involve faster reviews of prescription drugs ...
  • Regulatory NewsRegulatory News

    China to Begin Priority Reviews of Medical Devices in January 2017

    China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. The move is part of CFDA’s implementation of reforms to its approval systems for drugs and devices, and to meet the clinical demands of medical devices. According to the law firm Ropes & Gray , the new policy, first drafted in June, will allow applicants with a Class II device (limited to importe...
  • Regulatory NewsRegulatory News

    FDA and CMS Parallel Reviews of Devices to Continue

    A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...