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  • Regulatory NewsRegulatory News

    EMA revises methodological guidance for trials impacted by COVID-19

    Following a four-week public consultation, the European Medicines Agency (EMA) on Monday revised its guidance on methodological considerations for ongoing clinical trials amid the coronavirus disease (COVID-19) pandemic.   The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing th...
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    EMA recommends eight new medicines, refuses one

    A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.   The human medicines committee (CHMP) of EMA recommended a refusal of the marketing authorization for Daiichi Sankyo’s Turalio (pexidartinib), which was to be used to treat tenosynovial giant cell tumors. The agency cited concern for small improvement in clinical outcomes and uncertainty about dur...
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    FDA seeks input on genotyping for pediatric codeine use

    The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.   Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some cir...
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    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 The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).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...
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    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...
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    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...
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    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...
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    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,...
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    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...
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    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 ...
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    AACR: Minority accrual in clinical trials is a team sport

    Those who conduct clinical trials are missing a broad swath of the US population, with implications that not only reach into issues of equity and justice, but may also limit the generalizability of study findings, said a cancer researcher speaking at the American Association for Cancer Research annual meeting.   “Without adequate minority representation, it is difficult for us to fully be able to generalize the effects regarding the toxicity or efficacy or a medication...
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    Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

    US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (COVID-19) pandemic.   User fee goals, policy review   Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that FDA, “Has maintained the same pace of meeting its goals on applications for medical produc...