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  • Regulatory NewsRegulatory News

    FDA issues final guidance on inspections of medical device establishments

    The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).   The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspect...
  • Feature ArticlesFeature Articles

    Sarcopenia: Potential interventions for a newly recognized disease

    This article discusses sarcopenia, a newly recognized skeletal muscle disease. The authors review the disease, its diagnosis, the role of malnutrition in muscle deterioration, nutritional interventions, and EU regulatory considerations. They conclude that good nutritional health, physical activity, and pharmacologic options are the most effective early interventions. The most promising nutritional interventions are high-quality, protein-enriched supplements and multivitami...
  • ReconRecon

    Recon: FDA rejects AbbVie eye drug BLA; Novartis, Alcon to pay $347M to settle bribery investigations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis, Alcon Pay $347 Million to Settle Bribery Probes ( WSJ ) ( STAT ) ( DOJ ) FDA Approves Zogenix's Drug for Rare Childhood Epilepsy ( Reuters ) ( STAT ) ( FDA ) AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection ( Fierce ) ( Endpoints ) ( Press ) DBV lays off employees, scales down programs after receiving no word from FDA ( Endpoints )...
  • Regulatory NewsRegulatory News

    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
  • Regulatory NewsRegulatory News

    Revise remdesivir EUA to add registry, say researchers

    The US Food and Drug Administration (FDA) should create a patient registry to track key information about COVID-19 patients treated with remdesivir, according to three Harvard Medical School researchers. The researchers also called for FDA to begin negotiations with Gilead, which markets remdesivir, about pricing for the antiviral drug.   In a Viewpoints article published yesterday in JAMA, Ameet Sarpatwari, PhD, JD, and coauthors noted that FDA’s 1 May emergency use...
  • Regulatory NewsRegulatory News

    EMA recommends remdesivir to treat COVID-19, authorization expected next week

    Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.   EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug t...
  • RoundupsRoundups

    EU Regulatory Roundup: Regulators propose 40 actions to cut risk of medicine impurities

    European regulators have used their experience with the sartan contamination crisis to draw up a list of 40 recommendations for how to stop impurities from making their way into finished medicines.   Last year, members of the European regulatory network began considering the lessons learned from the discovery of N-nitrosamines in sartans and other classes of medicines. After receiving pushback from industry late last year, they have published a list of 40 recommendatio...
  • ReconRecon

    Recon: NIH may own IP for Moderna COVID-19 vaccine; UniQure sells gene therapy rights to CSL for $450M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump’s Drug Push Still Keeps Door Open for Banned Indian Firm ( Bloomberg ) Bolton casts light on Trump’s deference to China on coronavirus ( Politico ) Trump administration ending support for drive-thru testing sites ( Politico ) Breakthrough Drug for Covid-19 May Be Risky for Mild Cases ( NYTimes ) The NIH claims joint ownership of Moderna's coronavirus va...
  • Regulatory NewsRegulatory News

    FDA gives Project Renewal update at AACR

    Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress on a pilot FDA effort to modernize labels for these drug was shared by Patricia Keegan, MD, acting associate director for medical policy at the FDA’s Oncology Center of Excellence, at the virtual annual meeting of the American Association for Cancer Research.    Project Renewal, begun at the end of 2018,...
  • Regulatory NewsRegulatory News

    FDA finalizes bacterial pneumonia drug development guidances

    The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia.   Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/ph...
  • Regulatory NewsRegulatory News

    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
  • RoundupsRoundups

    FDA Approvals Roundup: Tazverik, Crysvita, Xpovio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Tazverik extended as therapy for mutated follicular lymphoma Epizyme’s Tazverik (tazemetostat) has been granted accelerated approval for treating adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved companion diagnostic, the cobas EZH2 Mutation Test (Roche...