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  • 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...
  • 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 ...
  • Regulatory NewsRegulatory News

    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...
  • FDA to sponsors: Early communication key during COVID-19

    Virtual meetings – a staple of business life during the COVID-19 pandemic – are an option for sponsors who seek meetings with the US Food and Drug Administration. Best routes of communication with the FDA both for coronavirus-related and other submissions and tips for having productive virtual meetings were shared with attendees of the virtual DIA 2020 global annual meeting by Khushboo Sharma, deputy director of operations at the Office of New Drugs at FDA’s Center for Dru...
  • Regulatory NewsRegulatory News

    Lawmakers ask FDA to outline COVID-19 vaccine approval process

    Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...
  • Regulatory NewsRegulatory News

    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...
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    FDA explains COVID-19 impact on MDUFA goals, meetings

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease (COVID-19) public health emergency on formal meetings and applications for medical devices.   FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings , ...
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    FDA: Follow CDC guidance for COVID-infected employees

    A new guidance from the US Food and Drug Administration clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their employees.   Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US Centers for Disease Control and Prevention (CDC). This guidance h...
  • Regulatory NewsRegulatory News

    European Commission proposes relaxing GMO regs for COVID-19 vaccines

    A proposal to adjust European Union regulation of genetically modified organisms (GMOs) would relax requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.   “The policy objective of this proposed regulation is to ensure that clinical trials with medicinal products for human use...
  • Regulatory NewsRegulatory News

    New accelerator to boost real-world COVID-19 diagnostics

    A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19.    The Diagnostics Evidence Accelerator is a joint project between the Reagan-Udall Foundation for the Food and Drug Administration and the nonprofit Friends of Cancer Research ; more than 50 collaborators were ...
  • Regulatory NewsRegulatory News

    FDA offers statistical guidance for trials impacted by COVID-19

    The US Food and Drug Administration (FDA) on Wednesday issued immediately effective guidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial integrity and mitigating the effects of coronavirus disease (COVID-19) public health emergency on clinical trials.   The new document follows the agency’s guidance on the conduct of clinical trials amid the pandemic, which has been updated several times to include additional questions and...
  • Regulatory NewsRegulatory News

    FDA yanks EUA for serology test

    The US Food and Drug Administration (FDA) on Tuesday revoked the emergency use authorization (EUA) granted to Chembio Diagnostic Systems Inc. for its DPP COVID-19 IgM/IgG System based on several sets of data indicating that the test generates false results at a higher rate than expected. This is the first revocation of an EUA for a SARS-CoV-2 serology test during the COVID-19 public health emergency. The system in question is an antibody test for the novel coronavirus; ...