The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
  • Regulatory NewsRegulatory News

    Pandemic prompts mask, ventilator EUAs from FDA

    This week, the US Food and Drug Administration granted emergency use authorizations (EUAs) to three ventilator-related devices, issued an umbrella EUA for disposable, single-use surgical masks and provided updated information on “in-use time” for certain drugs used to treat patients with COVID-19, the novel coronavirus.   Ventilator-related EUAs The US Food and Drug Administration (FDA) on 4 August issued EUAs for three devices that relate to mechanical ventilation o...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom and Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Pot...
  • Regulatory NewsRegulatory News

    FDA updates bioresearch monitoring e-submission guide

    A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.   The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework la...
  • ReconRecon

    Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants expedited review to Biogen's Alzheimer's drug ( Reuters ) ( Bloomberg ) ( STAT ) Trump Signs Executive Order to Boost US Production of Essential Medicine ( WSJ ) ( STAT ) Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. ( Barron’s ) Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV ( Bloomberg ) Pfizer to make Gi...
  • Feature ArticlesFeature Articles

    Interacting with competent authorities during COVID-19 – A European perspective

    This article covers direct interaction with various European authorities in regard to initial and amendment submissions and notifications related to urgent safety measures in response to the COVID-19 pandemic. The authors contacted selected European authorities to solicit data on submission events during 1 March and 30 June 2020. They found that the first 6-12 weeks of the pandemic presented challenges to numerous stakeholders but, after adjustments, the number of trials s...
  • Regulatory NewsRegulatory News

    EMA addresses risk evaluation, mitigation for nitrosamines

    An updated question-and-answer document from the European Medicines Agency (EMA) provides guidance on handling nitrosamine impurity testing for marketing authorization holders.   Marketing authorization holders (MAHs) are to perform a risk evaluation to ascertain whether chemically synthesized active pharmaceutical ingredients (APIs) are at risk for containing nitrosamines by 31 March 2021. Products containing biological APIs should undergo this first step in risk eval...
  • Regulatory NewsRegulatory News

    FDA: Most postmarketing requirements, commitments progressing on schedule

    In its latest annual report on drugmakers’ performance in conducting postmarket requirement (PRMs) and postmarketing commitments (PMCs), the US Food and Drug Administration (FDA) says that most studies are progressing on schedule.   Background   A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct, but is not ...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
  • RoundupsRoundups

    Euro Regulatory Roundup: EMA clears mutual recognition partners to co-audit GMP inspectorates

    The European Medicines Agency (EMA) has changed its joint audit program guidance to permit the involvement of its international peers as co-auditors. The revised guidance gives regulatory agencies with mutual recognition agreements (MRAs) with EMA the chance to take part in audits of the good manufacturing practice (GMP) inspectorates of national authorities.   Working with EMA, the Heads of Medicines Agencies (HMA) set up the audit program to monitor the implementatio...
  • ReconRecon

    Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Plans Order Seeking to Return Drug Production to US ( Bloomberg ) ( Politico ) ( STAT ) ( Endpoints ) ( Reuters ) FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ( Washington Post ) FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 ( NPR ) Trump says coronavirus vaccine possible before Nov. 3 ( Reuters...
  • Regulatory NewsRegulatory News

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...