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  • RoundupsRoundups

    Asia-Pacific Roundup: TGA plans changes to assistive technology oversight

    Australia’s Therapeutic Goods Administration (TGA) is set to limit its definition of assistive technology to low-risk products to clarify which devices are subject to its oversight. TGA chose the revised definition despite a consultation revealing opposition to the change from some trade groups.   In September, TGA held a consultation to advance reforms proposed by the Expert Panel Review of Medicines and Medical Devices Regulation. The panel called for TGA to remove p...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    13 Earned Regulatory Affairs Certification (RAC) in midst of COVID-19 pandemic; Many others opt for future test date

    Thirteen individuals passed the Regulatory Affairs Certification (RAC) exam during the recent spring exam period, RAPS announced today. More than 90% of those who had initially registered to take the exam in the spring transferred to a later exam period, as most RAC test centers were forced to close temporarily in response to the COVID-19 pandemic. Nearly all registrants opted to take the exam at some point, rather than cancelling. In May, RAPS announced a pilot progr...
  • Regulatory NewsRegulatory News

    Gene therapies: Industry asks for clarification on FDA’s sameness guidance

    Biotech companies and industry groups are raising questions about the US Food and Drug Administration’s (FDA) recent draft guidance on interpreting sameness of gene therapy products under its orphan drug regulations.   The draft guidance, issued for comment in January, explains how FDA intends to determine the sameness of two gene therapies intended for the same use or indication for the purposes of awarding orphan drug designation and exclusivity. (RELATED: FDA fina...
  • 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...
  • ReconRecon

    Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for targeted cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump signs orders aimed at lowering drug prices in largely symbolic move ( Washington Post ) ( STAT ) ( NYTimes ) ( Reuters ) Meadows says White House is 'hopeful' it can announce new coronavirus therapies 'in the coming days' ( The Hill ) Gilead's second act in cell therapy gets its first approval ( BioPharmaDive ) ( Endpoints ) ( FDA ) Moderna gets further ...
  • 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...
  • Regulatory NewsRegulatory News

    EMA: Thumbs up for 11, down for 2 new medicines

    At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.   Dapirivine Vaginal Ring is meant to reduce the risk of infection with HIV, in situations where oral pre-exposure prophylaxis is not used, ...
  • 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...
  • ReconRecon

    Recon: EU looks to pay less than $40 per COVID-19 vaccine; Taro to pay upwards of $200M to settle price-fixing suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump will sign executive orders on lowering drug prices on Friday: White House ( Reuters ) Trump drops plan to eliminate government drug rebates ( Politico ) US Clears Way for Drugmakers to Share COVID Antibody Capacity ( Reuters ) Taro Pharmaceuticals to pay more than $200 million to settle US price-fixing probe ( Reuters ) ( DOJ ) AstraZeneca's lung diseas...
  • Feature ArticlesFeature Articles

    Recasting CAPA as a continuous improvement process

    This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.   Introduction Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a stru...
  • 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...