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  • Regulatory NewsRegulatory News

    Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’

    The European Medicines Agency’s (EMA) Executive Director Guido Rasi on Monday told a European Parliament committee that the agency could grant conditional marketing authorization to Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) in a matter of days.   “It might be that a conditional marketing authorization can be issued in the coming days, subject to the data that has been submitted,” Rasi said, adding that he does not believe the drug is ready to ...
  • Regulatory NewsRegulatory News

    Standalone at-home COVID-19 nasal swab kit receives EUA

    A nasal swab kit that allows individuals to collect their own samples for COVID-19 diagnostic testing has been granted an emergency use authorization (EUA) by the US Food and Drug Administration (FDA).   The prescription-only kit may be used by individuals after a healthcare provider reviews their responses to an online screening questionnaire. FDA issued the EUA to Everlywell, Inc. for use with two different diagnostic tests to detect SARS-CoV-2, the virus that caus...
  • Regulatory NewsRegulatory News

    FDA updates COVID-19 clinical trials guidance to address serious adverse events

    The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address how and when sponsors and application holders should report serious adverse events (SAE).   The latest update to the guidance comes just days after FDA added new questions and answers to the document addressing the use of alternate laboratory or imaging centers, video conferencing and postmarketing studies. (...
  • Regulatory NewsRegulatory News

    FDA addresses interstate distribution of compounded drugs in new MOU

    The US Food and Drug Administration (FDA) has developed a standard memorandum of understanding (MOU) with the states that addresses interstate distribution of compounded drugs.   Under the MOU , expected to be signed by 45 states, pharmacy compounders that distribute more than 50% of their compounded drug products interstate will be identified by the states. States will be required to report certain information about these compounders to the FDA.   The 50% thresho...
  • Feature ArticlesFeature Articles

    Using risk management to support outsourcing activities

    This article outlines organizational risks and benefits with respect to third-party vendors and partnerships in regulatory affairs functions. It also discusses the different controls available to apply an effective risk management program in an organization.   Introduction   The use of contracted or third-party services can be an effective way for organizations to resource projects or programs. This way of working has been a growing trend in business operations, e...
  • ReconRecon

    Recon: Moderna sees immune response in Phase 1 study; GSK says monthly injection tops Truvada in HIV prevention trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Early data show Moderna Covid-19 vaccine generates immune response ( STAT ) ( NYTimes ) ( Reuters ) Gilead to end coronavirus drug trials, adding to access worry: researchers ( Reuters ) Trump Vows Vaccine by End of Year, and Mobilizes Military to Help ( NYTimes ) ( STAT ) US to stockpile vaccine candidates as trials continue: health secretary ( Reuters ) Tru...
  • Regulatory NewsRegulatory News

    EMA officials lay out need for ‘large, decision-relevant’ COVID-19 trials

    Top officials from the European Medicines Agency (EMA) say that international coordination is needed to ensure that clinical trials for treatments and vaccines for coronavirus disease (COVID-19) are conducted in a way that yields actionable and conclusive results.   “Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone clinical trials with a small number...
  • Regulatory NewsRegulatory News

    Swedish notified body is 14th designated under MDR

    Sweden’s Intertek Medical Notified Body AB on Friday became the 14 th notified body designated under the EU Medical Devices Regulation (MDR).   The newly designated notified body is the fifth to be designated in 2020, following the designation of German notified body mdc medical device certification GmbH last month, and the first to be designated in Sweden. (RELATED: German notified body is 13th designated under MDR as MHRA plots delay guidance , Regulatory Focu...
  • Regulatory NewsRegulatory News

    EMA waives certain GMP inspection fees during COVID-19

    The European Medicines Agency (EMA) this week announced it is waiving fees for on-site good manufacturing practice (GMP) inspections of drugmakers and blood establishments that have undergone remote inspections during the coronavirus disease (COVID-19) pandemic under certain circumstances.   Specifically, EMA says it will fully waive fees for sites that undergo remote inspections where GMP compliance cannot be confirmed and the inspection must be rescheduled “due to th...
  • ReconRecon

    Recon: Pfizer plans Phase III study for DMD gene therapy; FDA rejects Blueprint cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says efficacy of its Duchenne gene therapy outweighs side effects ( STAT ) ( Endpoints ) ( Reuters ) After a PhIII failure, the FDA delivers Blueprint an expected CRL ( Endpoints ) ( Reuters ) Trump Weighs Made-in-US Order for Vital Drugs, Devices ( Bloomberg ) Trump administration to expand strategic stockpile for pandemic needs ( Politico ) Convalesc...
  • Regulatory NewsRegulatory News

    WHO issues guidance for prequalified products amid COVID-19

    The World Health Organization (WHO) this month issued guidance detailing its expectations and flexibilities during the coronavirus (COVID-19) pandemic for manufacturers, laboratories and contract research organizations taking part in the agency's prequalifications programs. Localized adjustments in processes and procedures may be necessary for manufacturing, clinical trial and testing organizations due to the coronavirus pandemic, but should aim to minimize the risk of ...
  • Regulatory NewsRegulatory News

    EMA official says COVID-19 vaccine could be approved in a year

    A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency’s top official overseeing anti-infectives and vaccines, said Thursday.   Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September .   “I have to stress that...