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  • Regulatory NewsRegulatory News

    Drugmakers get return-to-normal guidance from FDA

    A new temporary guidance for drug and biologics manufacturers from the US Food and Drug Administration (FDA) details recommendations for returning to normal production operations during the public health emergency of the COVID-19 pandemic.   “This guidance provides recommendations to help manufacturers prioritize products as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduce...
  • Regulatory NewsRegulatory News

    Wide swath of online opioid sellers warned by FDA

    Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.   Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tr...
  • Regulatory NewsRegulatory News

    FDA clarifies EUAs for COVID multi-analyte respiratory panels

    Manufacturers can request emergency use authorizations under the public health emergency of the coronavirus pandemic for multi-analyte respiratory panels, the US Food and Drug Administration (FDA) clarified on 9 September.   The agency added a new item to its questions and answers (Q&As) for laboratories and manufacturers of tests for SARS-CoV-2, the virus that causes COVID-19.   The new Q&A cites “the overlap in signs and symptoms between SARS-CoV-2 and other resp...
  • RoundupsRoundups

    FDA Approvals Roundup: Gavreto and Trulicity

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approval Gavreto approved for metastatic lung cancer with RET gene fusions Blueprint Medicines’ Gavreto (pralsetinib capsules) has been granted accelerated approval for treating adults with metastatic non‒small cell lung cancer (NSCLC) whose tumors test positive for rearranged during transfection (RET) fusion in an accompanying biomarker assay.   The ass...
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    FDA updates PK guidance for patients with impaired renal function

    The US Food and Drug Administration (FDA) has updated its draft guidance for the design and analysis of trials to assess how impaired renal function impacts the pharmacokinetics and pharmacodynamics of investigational drugs. The guidance , issued on 03 September 2020, provides an update to a previous draft issued in March 2010. Specifically, the new document offers updated advice on when a standalone pharmacokinetic study is necessary, the appropriate study design, con...
  • Regulatory NewsRegulatory News

    FDA warns firm: Test batches before, not after release

    An Indonesian firm was warned by the US Food and Drug Administration (FDA) for failures in product testing and method validation, among other breaches of current good manufacturing practice (CGMP).   In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released. “This discrepancy on batch release documents demonstrates a concern regardin...
  • ReconRecon

    Recon: China vaccinates 100K for COVID; EUA for Roche COVID-flu combo test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Genentech scores sixth FDA approval in lung cancer with Gavreto ( Pharmafile ) US FDA Personnel Costs Drop: Is the Next Generation Taking Over? ( Pink Sheet ) Gottlieb: Staged Access To Coronavirus Vaccine Possible Through EUA ( Pink Sheet ) Why Saving The Economy Or Tackling The Pandemic Is A False Dilemma ( Forbes ) Here’s how Trump could bigfoot the FDA an...
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    EMA recommends pulling ulipristal acetate for fibroids

    An oral treatment for uterine fibroids should have its European Union marketing authorization revoked, according to the safety committee of the European Medicines Agency (EMA).   Citing the possibility of serious liver injury from ulipristal acetate, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the revocation of marketing authority for the 5 mg oral tablets, which are marketed as Esmya and generics. The medication was authorized in the EU to tre...
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    COVID convalescent plasma guidance gets EUA updates

    Guidance for industry on the use of convalescent plasma for patients with COVID-19 has been updated to reflect the 23 August Emergency Use Authorization (EUA) for the investigational product. The guidance clarifies which pathways are available for use of COVID-19 convalescent plasma and announces a period of enforcement discretion for transition to collection requirements outlined in the EUA.   Updates to the US Food and Drug Administration (FDA) guidance account for...
  • Regulatory NewsRegulatory News

    EMA finalizes pediatric trial preparedness framework

    The European Medicines Agency (EMA) has released the final version of a framework for pediatric clinical trial preparedness. The final document aims to “increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan within which a trial is embedded,” according to EMA.   This framework’s releas...
  • RoundupsRoundups

    FDA Roundup: Sogroya, Onureg, Winlevi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Sogroya okayed as weekly therapy for adult growth hormone deficiency Novo Nordisk’s Sogroya (somapacitan-beco injection) has been approved as the first once-weekly, human growth hormone (hGH) therapy for adults with growth hormone deficiency.   Until now, the only treatment option for patients with the disorder has been a daily formulation of t...
  • Regulatory NewsRegulatory News

    FDA updates deferral guidance for blood and plasma donation

    An update to guidance for industry on reducing the risk of transmission of Creutzfeldt-Jacob disease (CJD) through blood and blood components clarifies terminology and recommendations for patients who have received cadaveric pituitary human growth hormone. Some previous travel-based deferrals have also been revised or eliminated.   The revised guidance from the US Food and Drug Administration (FDA) addresses screening for variant CJD (vCJD) as well as other transmissib...