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  • Feature ArticlesFeature Articles

    Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
  • RoundupsRoundups

    FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ryaltris okayed for seasonal allergic rhinitis Glenmark’s Ryaltris ( olopatadine and mometasone furoate; nasal spray ) has been approved for seasonal allergic rhinitis in adults and pediatric patients aged 12 years or older.   The approval of Ryaltris was based on findings from two multicenter, randomized, double-blind, placebo-and active-co...
  • RoundupsRoundups

    FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Quviviq nabs go-ahead for insomnia in adults Idorsia’s Quviviq ( daridorexant; tablets ) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.   The approval was based on efficacy findings in two studies ( Study 1 and Study 2 )...
  • Regulatory NewsRegulatory News

    Chinese firm warned for making OTC eye drops without microbiological safeguards

    The US Food and Drug Administration (FDA) warned Chinese drugmaker Hubei Kangzheng for having inadequate microbiological controls to prevent contamination of its over-the-counter (OTC) eye drops. These violations partly stem from the firm’s misguided notion that the eye drops are non-sterile drugs, thus not to more stringent microbiological controls.   The warning letter was issued on 23 November 2021 and posted to FDA’s website on 11 January. It follows a nine-day ins...
  • Regulatory NewsRegulatory News

    Manufacturers object to provisions in FDA’s microbiological quality guidance

    An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality considerations for non-sterile drugs (NSDs), which they say proposes onerous new microbiological testing requirements.   The 24-page draft guidance was released for comment in September 2021 and is designed to help manufacturers control microbiological contamination of their non-sterile drugs and ste...
  • Regulatory NewsRegulatory News

    FDA issues draft guidance on assessing physiologic closed-loop control devices

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with physiologic closed-loop control (PCLC) technology to ensure their safe and effective use. Submissions should carefully weigh patient and device-related risks as well as use-related hazards.   These devices consist of a sensor that measures a physiologic variable from the patient, a controller/control...
  • RoundupsRoundups

    FDA Approvals Roundup: Tarpeyo, Dartisla ODT, Yusimry

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Tarpeyo approved for reducing proteinuria in IgA nephropathy Calliditas Therapeutics’ Tarpeyo (budesonide) delayed release capsules were granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, also known as Berger’s disease, who are at risk of rapid disease progression. Approval of Tarpeyo wa...
  • Regulatory NewsRegulatory News

    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
  • ReconRecon

    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
  • RoundupsRoundups

    FDA Approvals Roundup: Apretude, Vyvgart, Tezspire

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals  Apretude cleared for HIV pre-exposure prevention  Viiv’s Apretude (cabotegravir extended-release injectable suspension) has been  approved  for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.  Approval of Apretude was based on safety and efficacy findings from two randomized, dou...
  • Regulatory NewsRegulatory News

    This week at FDA: Medtronic MiniMed problems; Device classification flurry

    Welcome to 2021’s last issue of This Week at FDA. This week saw a year-end flurry of device classifications; we are also sharing news of three noteworthy device warning letters and a citizen petition response that closes with FDA’s referring a firm to the Federal Trade Commission (FTC) for anticompetitive practices.    RAPS offices are closed 23 December – 2 January. Regulatory Focus will resume publication on 3 January. From our team to you, our valued readers, best...
  • Regulatory NewsRegulatory News

    FDA removes in-person dispensing requirement for abortion medication

    The US Food and Drug Administration (FDA) is modifying the shared Risk Evaluation and Mitigation Strategy (REMS) for mifepristone products to allow women to continue to access the abortion medication through the mail via a certified prescriber.   The move, highlighted on FDA’s mifepristone information webpage and in updates to an associated question-and-answer (Q&A) page on 16 December, makes permanent the eased restrictions permitted during the COVID-19 pandemic. At...