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  • RoundupsRoundups

    FDA Approvals Roundup: Olumiant, Enhertu

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Olumiant use extended for hospitalized COVID-19 patients needing oxygen support Eli Lilly’s Olumiant (baricitinib tablets ) has been granted a new indication for treating COVID-19 in hospitalized adults who require varying degrees of ventilation/oxygen support.   Olumiant has been available to treat COVID-19 in the US under emergency use ...
  • Regulatory NewsRegulatory News

    FDA officials discuss prioritizing inspections, QMSR transition

    Officials from the US Food and Drug Administration (FDA) explained how the agency is prioritizing medical device inspections as it resumes normalized operations. They also announced a new “careful and cautious” approach to conducting foreign inspections.   At the 4 May virtual MedCon Conference which was hosted by the Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS), officials also addressed how it will balance the u...
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    FDA’s Office of Compliance details enforcement actions in 2021

    The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...
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    Remote interactive evaluations: FDA official discusses lessons learned

    To ensure the success of remote interactive evaluations (RIEs), the pharmaceutical industry should treat these evaluations with the same level of attention to detail as onsite inspections,  said Alexander Gontcharov, a staff fellow with the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) during the second day of FDA’s Generic Drug Forum on 27 April.   At the meeting, Gontcharov shared some of the lessons learned from the agency’s intera...
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    FDA official discusses common deficiencies derailing ANDAs

    The US Food and Drug Administration (FDA) rejected a fewer number of abbreviated new drug applications (ANDAs) in FY 2021 through its refuse-to-receive (RTR) mechanism compared to previous years, said Peter Enos, a reviewer with the agency’s Office of Generic Drugs. He attributed the improvement to increased transparency with industry, better filing practices and enhanced communication with applicants.   Enos also addressed how industry can improve their submissions to...
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    FDA proposes plan to mail back unused opioids

    The US Food and Drug Administration (FDA) proposed to modify its Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) program on Wednesday to require that a mail-back envelope be supplied along with prescriptions filled in the outpatient setting, so that unused opioids can be returned for disposal. Mail-back envelopes would be postage-paid.   The proposal aims to reduce the risk that unused pills will cause accidental overexposure or addiction.   “The...
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    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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    FDA warns that some prenatal screening tests can generate false results

    Some non-invasive prenatal tests  (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic purposes, the US Food and Drug Administration (FDA)  warned on Tuesday.   The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.   These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are ...
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    FDA outlines criteria for granting waivers for pH adjusters in generic drugs

    The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or otic abbreviated new drug applications (ANDAs). FDA said in certain circumstances, certain differences in pH adjusters “may be scientifically appropriate and acceptable.”   This guidance outlines the process for requesting a waiver from complying with the generic drug regulations under §314.94(a)(9)(iii) and (iv). T...
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    FDA proposes to rate pharmaceutical manufacturing facilities

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper . The ratings would be publicly available.   “QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for s...
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    Unannounced FDA inspections have started in India, not China

    The US Food and Drug Administration (FDA) unannounced foreign inspections program has resumed in India but is still paused in China due to local COVID-19 restrictions, Judith McMeekin, FDA associate commissioner for regulatory affairs, said on 6 April during a webinar sponsored by the Alliance for a Stronger FDA.   Members of Congress have expressed concern that FDA’s drug inspection program is inadequate to meet the meet the growth in foreign drug manufacturing facili...
  • RoundupsRoundups

    FDA Approvals Roundup: Vijoice, Hyftor, Yescarta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Vijoice okayed for PIK3CA-related overgrowth spectrum Novartis’s Vijoice ( alpelisib ) has been granted accelerated approval for treating severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in adults and children aged 2 years or older who require systemic therapy.   This indication for Vijoice, a kinase inhibitor, was approved...