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  • Regulatory NewsRegulatory News

    FDA announces FY 2022 GDUFA science and research priorities

    The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.   The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.   The workshop was held i...
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    EU official says ICH Q6B is outdated and needs revision

    The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.   Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webi...
  • Regulatory NewsRegulatory News

    ICH recaps progress made over past year, charts new topics

    The International Council for Harmonisation (ICH) announced that “significant milestones” were reached over the past year, including the adoption of the widely anticipated guideline on general considerations for clinical studies and the release of question-and-answer guidelines related to the electronic Common Technical Document (eCTD).   Other accomplishments ICH cited in a recent summary of a mid-November virtual meeting include the advancement of a guideline on qu...
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    Smiths Medical warned by FDA for multiple violations

    The US Food and Drug Administration (FDA) slapped Smiths Medical in Minneapolis, MN with a warning letter for inadequate procedures for handling medical device reports (MDRs), faulty handling of complaints, inadequate validation processes, and lax corrective and preventative actions (CAPA) procedures. The company makes blood warmers and infusion pumps.   The warning letter was issued on 1 October and posted on 23 November. It follows a recent recall of the company’s ...
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    FDA suggests alternative approaches for nitrosamine risk assessments

    The US Food and Drug Administration (FDA) has suggested that manufacturers consider using certain antioxidants or excipients, such as sodium carbonate, to their drug products to inhibit the formation of nitrosamine impurities.   These approaches were outlined in recent update on possible mitigation strategies to reduce the risk of nitrosamine impurities in drug products. The update was prompted by reports of certain types of nitrosamine impurities that formed in “sever...
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    EMA provides advice on using molnupiravir; will soon render decision on J&J’s COVID vaccine booster

    The European Medicines Agency (EMA) on 19 November issued advice to member states on how to use Merck Sharp & Dohme’s and Ridgeback Biotherapeutics’ antiviral drug Lagevrio (molnupiravir), an oral antiviral drug for treating patients with COVID-19, prior to its formal EU authorization. This action was taken to combat “rising rates of infection and deaths due to COVID-19 across the EU," EMA said.   In related developments, the European regulator also announced that it...
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    FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

    The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.   Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading...
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    CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies

    The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)   last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also recommended the rejection of a treatment for neovascular (wet) age-related macular degeneration.   CHMP recommended authorizing Celltrion Healthcare Hungary’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab) for tre...
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    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
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    FDA touts success and challenges in biosimilar development

    A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the program in the oncology space, with less activity in other treatment areas. The costly and lengthy process of getting biosimilars approved is also a deterrent to wider uptake.   Jacqueline Corrigan-Curay, principal deputy center director for FDA’s Center for Drug Evaluation...
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    FDA taking incremental approach to launching KASA reviews

    The US Food and Drug Administration (FDA) is taking a “step-wise” approach to implementing its Knowledge-Aided Assessment and Structured Application (KASA) drug review program. The review program has already launched for abbreviated new drug applications (ANDAs) for solid oral dosage forms and will eventually be rolled out for new drug applications (NDAs) and ANDA liquid dosage forms in FY 2023. KASA will be phased in for investigational new drug applications (INDs) and po...
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    Pandemic has challenged industry’s implementation of DSCSA

    The pharmaceutical industry and its trading partners are showing “uneven readiness” in implementing the serialization systems necessary to comply with the Drug Supply Chain Security Act (DSCSA) by the November 2023 deadline when these exchanges go live.   The pandemic may have prompted this rocky situation as trading partners focus efforts on “core response activities” and not DSCSA compliance, according to a recent survey released 1 November by the Healthcare Distribu...