• RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares process for certain remote inspections

    The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published its procedure for conducting remote compliance inspections related to drugs and regenerative medical products.   PMDA set out its approach to remote inspections late last year, before going on to post an English translation of the document last week. The document details the different steps of the remote inspection process and what applicants can do to prepare.   PMDA will inform an applic...
  • Regulatory NewsRegulatory News

    Australia’s TGA authorizes Pfizer COVID vaccine

    The Therapeutic Goods Administration (TGA) on Monday granted provisional approval to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for individuals aged 16 and older, making it the first COVID-19 vaccine authorized for use in Australia.   The approval follows a provisional determination by the agency in October allowing for the submission of the application under the provisional pathway. TGA has also granted provisional determinations for vaccines developed by Astra...
  • Regulatory NewsRegulatory News

    Stakeholders weigh in on big data at EMA forum

    Effective use of real-world data and other data gathered outside the clinical trial arena requires a unified, big-picture approach, according to a new report from the first-ever big data stakeholder forum held by the European Medicines Agency (EMA).   The regulator’s report on the 15 December 2020 forum highlighted the importance of collaboration in addressing some of the challenges of bringing real-world data (RWD) into the drug development process. Some of these incl...
  • Regulatory NewsRegulatory News

    OPDP's Gray reflects on 2020's challenges, successes

    Looking back to 2020, the acting director of the US Food and Drug Administration’s Office of Prescription Drug Promotion (FDA’s OPDP) highlighted the office’s major initiatives and successes.   Speaking in a “Conversations” interview hosted by FDA’s Center for Drug Evaluation and Research, Katie Gray, PharmD, spoke of inter-agency initiatives to encourage biosimilar competitiveness, how the pandemic changed the year’s course for OPDP, and future directions.   In th...
  • ReconRecon

    Recon: Merck stops development of COVID vaccines; Moderna developing booster against new COVID variants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck ends COVID vaccine program, cites inferior immune responses ( Reuters ) ( Endpoints ) ( STAT ) Pfizer Will Ship Fewer Vaccine Vials to Account for ‘Extra’ Doses ( NYTimes ) ( Politico ) US goal to squeeze more COVID shots from Pfizer vials hampered by syringe production ( Reuters ) Moderna says it believes vaccine will work against new variants ( Reuters...
  • Regulatory NewsRegulatory News

    Federal charges levied against COVID "vaccine" peddler

    Federal criminal charges have been filed against a man previously warned by the FDA for peddling unproven and unauthorized “vaccines” against COVID-19.   Johnny Stine, president of Oregon-based North Coast Biologics, previously received a May 2020 warning letter jointly issued by the US Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). In the letter, the agencies ordered him to cease “misrepresentations” made on Facebook and LinkedIn, as well a...
  • Regulatory NewsRegulatory News

    Brexit, medicine availability top EMA stakeholder report

    Brexit readiness, regulatory science strategic planning, and medicine availability topped the list of big-picture areas of engagement between the European Medicines Agency (EMA) and industry stakeholders in a newly released biennial report.   The EMA report , released Friday and covering the 2018-19 biennium, was presented to EMA’s Management Board in December 2020. It provides a high-level look at interaction between the European regulator and the pharmaceutical indu...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • ReconRecon

    Recon: Record-shattering 2020 healthcare investment; BIO layoffs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Who’s who in Biden’s health care team ( Medical Economics ) Biden begins presidency with aggressive healthcare agenda ( Healthcare IT News ) Biden Inherits a Vaccine Supply Unlikely to Grow Before April ( NYT ) Biden administration is trying to figure out what’s delaying Covid vaccine shots, CDC says ( CNBC ) How To Fix The Covid-19 Vaccine Rollout ( Forbes )...
  • Regulatory NewsRegulatory News

    Biden’s day one regulatory freeze

    Newly inaugurated President Joe Biden wasted little time in acting to halt former President Donald Trump’s “midnight regulations” and to revoke some of his predecessor’s controversial deregulatory orders in his first day in office.   Biden’s “regulatory freeze” memorandum will likely impact several moves by the Department of Health and Human Services (HHS) in the final days and weeks of the Trump administration that impact the US Food and Drug Administration (FDA), e...
  • Regulatory NewsRegulatory News

    Amid pandemic, EMA's 2020 authorizations ticked upward

    Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according to a new report from the agency highlighting the year’s regulatory activities.   In 2020, 97 new medicines were recommended for authorization by EMA; of these, 39 contain a new active substance (NAS). In 2019, EMA issued 66 positive opinions for medicines, 30 of which contained a NAS. The total numbers of n...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    What you need to know about taking the RAC exam online

    Traditionally, candidates for Regulatory Affairs Certification (RAC) have taken their RAC exams in person at one of more than 1,000 authorized testing centers around the world. But when the COVID-19 global health crisis forced most centers to close temporarily in the spring of 2020, RAPS launched a pilot program allowing exam-takers to sit for the exam remotely online. RAPS worked with its testing vendor, Scantron, to roll out a form of test administration called ‘l...