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  • RoundupsRoundups

    FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Tecartus okayed as first CAR-T therapy for MCL Kite’s Tecartus (brexucabtagene autoleucel), a customized, one-time therapy derived from a patient’s genetically modified T cells, has received accelerated approval for treating adults with relapsed or refractory mantle cell lymphoma (MCL).   It is the first chimeric antigen receptor T-cell (CAR...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • Regulatory NewsRegulatory News

    $3.2 billion FDA budget clears US House

    The US House of Representatives passed a four-bill appropriations minibus for fiscal year 2021 that includes an amendment giving the US Food and Drug Administration (FDA) the authority to recall drugs. The agency’s proposed budget also includes targeted boosts to spending for medical product and food safety activities and influenza vaccine manufacturing technologies.   Other targeted initiatives include cross-departmental initiatives designed to enhance food and medica...
  • Regulatory NewsRegulatory News

    Excipients group seeks GDUFA III participation

    Increasing the timely, safe, and cost-effective availability of generic drugs requires that excipient issues be addressed as an integral part of the process, said Priscilla Zawislak, Immediate Past-Chair of International Pharmaceutical Excipients Council (IPEC)-Americas.   Zawislak, speaking at the 21 June 2020 public hearing kicking off the reauthorization process for the third Generic Drug Fees User Amendments (GDUFA III), said that excipient manufacturers are also a...
  • Feature ArticlesFeature Articles

    US regulations for regenerative medicine advanced therapies

    This article examines US regulations and guidance documents for regenerative medicine advanced therapies (RMATs). The author describes the field of regenerative medicine, noting that it is expanding at an accelerated pace, and outlines some of the common terms associated with it. He also addresses the application process for these therapies, accelerated regulatory pathways, market access, and the outlook for RMATs. The author cautions that, as exciting as these therapies a...
  • Regulatory NewsRegulatory News

    PDUFA VII: FDA, industry preview their reauthorization wish lists

    At its first public meeting in the runup to the reauthorization of the Prescription Drug User Fee Act, the US Food and Drug Administration (FDA), industry and other stakeholders on Thursday shed light on their goals for what will be the agency’s seventh PDUFA program.   The meeting, held fully virtually for the first time due to the COVID-19 pandemic, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s new ...
  • Regulatory NewsRegulatory News

    FDA proposes reporting rule for Right to Try Act

    A new proposed rule issued by the US Food and Drug Administration (FDA) provides sponsors and manufacturers detailed guidance on the annual summary reporting required of them under the Right to Try Act.   “The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affa...
  • Regulatory NewsRegulatory News

    Opioid labeling to include naloxone counseling recommendation

    Labels for opioid pain medicines and opioid use disorder (OUD) treatments must now include a recommendation that naloxone availability be discussed as a routine part of prescribing these medicines, says the US Food and Drug Administration (FDA).   “We are requiring the drug manufacturers for all opioid pain relievers and medicines to treat OUD to add new recommendations about naloxone to the prescribing information,” said FDA in a Drug Safety Communication released tod...
  • Regulatory NewsRegulatory News

    FDA warns California-based CDMO, Mexican drugmaker

    The US Food and Drug Administration (FDA) earlier this month warned two companies, contract development and manufacturing organization (CDMO) Stason Pharmaceuticals and Mexican drugmaker Signa SA de CV.   Stason Pharmaceuticals, Inc.   In its warning letter to Irvine, CA-based CDMO Stason Pharmaceuticals, FDA cites the company for product testing and data integrity issues uncovered during a three-week inspection last October.   According to FDA, the company w...
  • RoundupsRoundups

    FDA Approvals Roundup: Xywav, Qutenza, Orphengesic

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Xywav gets the nod as a low-sodium option for narcolepsy   Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates oral solution) has been approved as a therapy for cataplexy or excessive daytime sleepiness in children aged 7 years or older and adults who have narcolepsy, a chronic and debilitating neurologic condition f...
  • Regulatory NewsRegulatory News

    Cannabis clinical research clarified in draft guidance

    A new draft guidance from the US Food and Drug Administration (FDA) provides detailed information on the conduct of clinical research using cannabis and cannabis-derived compounds, including how to calculate levels of delta-9 tetrahydrocannabinol (THC), cannabis’ main psychoactive ingredient.   The draft guidance recommendations, which pertain only to human drug development, “are intended to provide clarity” in the wake of the 2018 Farm Bill, which removed low-delta-...
  • Regulatory NewsRegulatory News

    FDA kicks off GDUFA III reauthorization process

    In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which included presentations by members of industry and the public, is the first of many that will shape the agency’s third GDUFA program.    GDUFA II, authorized in 2017, expires at the end of September 2022. The GDUFA II agreement had two major objectives in speeding access to ...