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  • 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

    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 ...
  • 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 ...
  • Regulatory NewsRegulatory News

    FDA’s COVID-focused vaccines adcomm: A preview

    On 22 October, the US Food and Drug Administration (FDA) will convene the first COVID-19-focused meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).   The meeting is not reviewing information about a specific vaccine; rather, the committee is convening “to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19,” according to the agenda . The committee is tasked with sorting through much tec...
  • Regulatory NewsRegulatory News

    FDA approves fewer generics in FY2020, ending record streak

    After four straight years of posting record numbers of abbreviated new drug application (ANDA) approvals, the US Food and Drug Administration (FDA) has broken its streak, approving 22% fewer generic drugs in FY2020 than it did in FY2019.   In FY2020, FDA approved a total of 909 ANDAs, 737 full approvals and 172 tentative approvals, compared to a record 1,171 ANDAs in FY2019. Complete responses also declined to 2,010 compared to 2,310 in FY2019. (RELATED: Another reco...
  • Participants sought for FDA nonclinical data exchange pilot

    The US Food and Drug Administration (FDA) is seeking volunteers to participate in a fit for use pilot program of electronic processing and analysis of nonclinical study data in developmental and reproductive toxicology.   The pilot will look at data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data implementation guide for Developmental and Reproductive Toxicology version 1.1 (SEND-DART)...
  • Feature ArticlesFeature Articles

    US-focused regulatory toolbox: The basics

    This article examines regulatory tools found mostly on the US Food and Drug Administration’s (FDA’s) website for use by regulatory affairs professionals interested in drug products and medical devices marketed in the United States.   FDA guidance documents 1 Guidance documents represent the agency’s current thinking or interpretation of a particular policy or topic. They are an especially useful tool for RA professionals dealing with issues such as drug development ...
  • RoundupsRoundups

    FDA Approvals Roundup: Inmazeb, Wakix, Venclexta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Inmazeb approved as first treatment for Ebola virus Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn combination) has been approved as the first treatment for Zaire ebolavirus (Ebola virus) infection in adults and children. The therapy received orphan drug and breakthrough therapy designations for treating the infection.   ...
  • Regulatory NewsRegulatory News

    With new guidance, FDA moves toward uniform postmarketing reporting

    A new draft guidance related to postmarketing requirements and commitments is available from the US Food and Drug Administration (FDA). The document details how drug and biologics marketers will use two forms for online submission of annual status report and other required postmarketing information.   The forms, FDA 3988 and 3989, are the mechanisms by which applicants will fulfill requirements for annual reporting on the status of postmarketing requirements (PMRs) and...
  • Regulatory NewsRegulatory News

    CHMP: Test all metformin for nitrosamines before release

    Medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market, said a committee of the European Medicines Agency (EMA) following its scheduled September meeting.   “As of October 2020, EMA and the national competent authorities are asking marketing authorization holders for metformin-containing medicines to test their medicines before releasing them onto the market,” said EMA’s Comm...