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

  • FDA-state compounding MOU now available for signing

    A standard memorandum of understanding between the US Food and Drug Administration (FDA) and the states regarding interstate distribution of compounded drugs is available for signing.   State boards of pharmacy or other state agencies have 365 days to sign the document. After that time, FDA intends to begin enforcing a provision of the Federal Food, Drug and Cosmetic Act (FD&C Act) that prohibits states that have not signed the MOU from distributing more than 5% of a c...
  • ReconRecon

    Recon: FDA delays decision on Spectrum drug due to COVID travel restrictions; Bayer to buy AskBio for up to $4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Spectrum Pharma's drug candidate due to travel curbs ( Reuters ) ( Endpoints ) Two Companies Restart Virus Trials in U.S. After Safety Pauses ( NYTimes ) ( FT ) South Korea pharma Celltrion's COVID test gets US emergency use authorisation ( Reuters ) U.S. disease expert Fauci says vaccine verdict due by early December ( Reuters ) Senate...
  • Regulatory NewsRegulatory News

    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...
  • Regulatory NewsRegulatory News

    Breast implant-lymphoma link probed by EC committee

    The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.   The EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued on report on the relationship between breast implants and anaplastic large cell lymphoma (BIA-ALCL). The committee’s charge encompassed use of implants both for breast reconstru...
  • Regulatory NewsRegulatory News

    EMA highlights multiple considerations when developing drugs for older adults

    In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. But the sole focus should not be on chronological age since patients of any age may experience similar needs or impairments. “For example, the need for an easy to ...
  • ReconRecon

    Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Facing vaccine doubts, US grapples with building confidence in coronavirus shots ( BioPharma Dive ) FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines ( STAT ) How pandemic fatigue and polarization led to Wisconsin’s massive Covid-19 outbreak ( Vox ) ( NPR ) Report finds coronavirus pandemic leading to 'unacceptable' shortage of US ...
  • Feature ArticlesFeature Articles

    Making the transition from regulatory manager to regulatory consultant

    This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.   ...
  • Regulatory NewsRegulatory News

    FDA plans master protocols to monitor COVID vaccine safety, efficacy

    After a vaccine against COVID-19 is authorized or approved, how will its safety and efficacy be assessed? In addition to ongoing postmarket surveillance requirements, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) will strive for near real-time safety and efficacy surveillance of COVID-19 vaccines.   FDA is currently developing master protocols to guide its safety and effectiveness oversight, said an FDA official duri...
  • Regulatory NewsRegulatory News

    Remdesivir receives FDA approval for COVID-19

    The US Food and Drug Administration (FDA) has given full approval to the first drug to treat COVID-19. The antiviral Veklury (remdesivir, Gilead Sciences) received approval on 22 October to treat older children and adults who are hospitalized with COVID-19.   Veklury had previously received an emergency use authorization EUA on 1 May 2020 for a broader population that also included hospitalized pediatric patients weighing 3.5 kg or more.   "The FDA is committed to ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    EC’s Erik Hansson among panelists for Euro Convergence opening plenary

    Erik Hansson, the European Commission’s deputy head of devices, will be among the expert panelists kicking off RAPS’ 2020 Euro Convergence , being held live online, 26–30 October. The 26 October plenary, Global Perspectives on the 2020 Regulatory Landscape, will feature 16 regulatory experts from organizations including government agencies, notified bodies and manufacturers. Hansson leads the EC’s operational team dealing with the implementation of the EU Medical Devic...
  • RoundupsRoundups

    Euro Roundup: UK revs up for COVID vaccine approval

    The United Kingdom has introduced legislation on the temporary authorization of unlicensed drugs and vaccines to support the rollout of COVID-19 products. Through the legislation, the UK is seeking to clarify the power to impose conditions on temporary authorizations and extend partial immunity from civil liability to pharmaceutical companies that outsource manufacturing.   Until the end of 2020, the European Medicines Agency (EMA) will handle the licensing of COVID-19...
  • ReconRecon

    Recon: Moderna completes enrollment in Phase 3 COVID vaccine study; Dr Reddy’s hit by cyberattack

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US An angry Azar floats plans to oust FDA’s Hahn ( Politico ) Moderna completes enrollment in large COVID-19 vaccine study ( Reuters ) Roche, Atea team up on potential COVID-19 pill ( Reuters ) US likely to have enough COVID-19 vaccines for all vulnerable Americans by year end: official ( Reuters ) Why the US doesn’t have an at-home coronavirus test yet ( Politi...