• Regulatory NewsRegulatory News

    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...
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    Euro Convergence: Experts advise on ways to manage the MDR grace period

    Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.   At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.   The EU Medical Device Regulations (MDR) is a new set of new regulatory require...
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    FDA authorizes Pfizer-BioNTech vaccine in children 12-15

    The US Food and Drug Administration (FDA) on Monday authorized Pfizer and BioNTech’s COVID-19 vaccine for use in adolescents 12 to 15 years of age.   "The FDA's expansion of the emergency use authorization [EUA] for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock in a statement. "Today's action allows for a younger popul...
  • Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
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    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
  • ReconRecon

    Recon: Lilly signs deals to boost India supply of antibody drugs; Inovio says COVID vaccine safe, effective in Ph. 2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial ( Reuters ) AstraZeneca weighs seeking full approval for Covid shot, skipping EUA ( WSJ ) ( Reuters ) Novavax not expected to seek COVID vaccine authorization until June at the earliest ( Washington Post ) Biden administration signals that FDA may allow abortion pill access via mail even...
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    PRAC investigates heart inflammation reports with Pfizer vaccine

    During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine.   EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up a review of reports of facial swelling in recipients of Pfizer’s COVID-19 vaccine, k...
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    Global regulators issue call for clinical trial data transparency

    World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”   Data related to a therapy or vaccine “must be published at the time of finalization of the regu...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab as well as Regeneron’s casirivi...
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    FDA awards two COA grants to study neurodevelopment disorders and nephrotic syndrome

    The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome.   The grants “provide avenues to advance the use of patient input as an important part of drug development that can foster innovation and the availability of safe and effective drugs,” said the agency’s 4 May ...
  • ReconRecon

    Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ) Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ) How Big Pharma finds sick users on Facebook ( TNW ) ( Ars ) Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ) The US opened pandora’s box on IP...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...