• 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    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.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have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...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...
  • RoundupsRoundups

    FDA Approvals Roundup: Entadfi, Zynrelef, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Entadfi okayed for benign prostatic hyperplasia Veru’s Entadfi (finasteride and tadalafil capsules) has been approved for treating urinary tract symptoms caused by benign prostatic hyperplasia (BPH), or enlarged prostate. The combination has also been shown to have less potential for adverse sexual side effects compared with finasteride mono...
  • Regulatory NewsRegulatory News

    FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps

    The US Food and Drug Administration (FDA) has recently released two draft guidances: one with advice for sponsors on the development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), and another offering efficacy and safety considerations for the development of bowel cleansing products for colonoscopy.     Guidance on CRSwNP drugs   The agency provided recommendations for sponsors involved in a CRSwNP drug’s development, including d...
  • Regulatory NewsRegulatory News

    Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...
  • Regulatory NewsRegulatory News

    This Week at FDA: Bardoxalone strikes out at adcomm; Updated device consensus standards

    Happy Friday – this week we’re juggling lots of end-of-year activity from the US Food and Drug Administration (FDA). Today and in the next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and background on industry’s reactions to other guidances whose comment periods have recently closed.   The Center for Drug Evaluation and Research (CDER) released its fall/winter 2021 regulatory science news update today....
  • Regulatory NewsRegulatory News

    FDA issues draft guidance on study designs using real-world data

    The US Food and Drug Administration (FDA) has issued draft guidance to industry on how real-world data (RWD) could be used in clinical trials and how it could be incorporated into the design of non-interventional studies.   The draft guidance , released Thursday, outlines the applicability of FDA’s investigational new drug application (IND) regulations to clinical study designs that use RWD and clarifies the agency’s expectations on new drug applications (NDAs) or bio...
  • RoundupsRoundups

    FDA Approvals Roundup: Xaciato, cutaquig, Rituxan

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xaciato okayed for treating bacterial vaginosis Daré’s Xaciato (clindamycin phosphate vaginal gel ) has been approved to treat bacterial vaginosis in patients aged 12 years or older.   The approval was based on findings from the Phase 3 multicenter, double-blind, placebo-controlled DARE-BVFREE study in which 307 patients from the indicate...