• ReconRecon

    Recon: FDA releases hundreds of pages of Trump-era emails; Biogen gene therapy misses study goals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Internal Trump-era emails reveal a plethora of celebs, companies vying for FDA’s attention ( Endpoints ) ( Politico ) ( FDA ) Biogen's experimental eye treatment fails to meet study goal ( Reuters ) ( Endpoints ) Fully vaccinated people can shed their masks in most places - CDC ( Reuters ) ( STAT ) Adolescents Can Get Routine Immunizations With Their COVID Sho...
  • Regulatory NewsRegulatory News

    To speed drug development, ICH proposes reducing rat carcinogenicity testing

    The International Council for Harmonization (ICH) recently announced a new draft guideline that proposes a “weight of evidence” approach to inform whether a two-year rat study would add value in evaluating a drug’s carcinogenic risks.     The proposed guideline provides more detailed guidance for drug developers who are considering whether rodent studies are needed to assess carcinogenicity. The ICH S1B(R1) addendum, once adopted, should be used in conjunction with t...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than 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’...
  • Regulatory NewsRegulatory News

    FDA calls for input on peptide evaluation

    The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids.   “For the purpose of this request, FDA is specifically interested in comments regarding the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides, as well as the effects of peptides on cardiac electrophysiology,” wrot...
  • Regulatory NewsRegulatory News

    House Dems press Becerra on FDA LDT oversight

    In a letter to Department of Health and Human Service (HHS) Secretary Xavier Becerra earlier this week, top Democrats on the House Energy and Commerce Committee pressed the health secretary to reverse a Trump-era policy that removed laboratory developed tests (LDTs), including those for COVID-19, from US Food and Drug Administration (FDA) oversight.   “Only FDA has the legal responsibility, as well as the experience and expertise, to evaluate the accuracy and reliabili...
  • 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 ...
  • ReconRecon

    Recon: FDA approves Heron’s non-opioid anesthetic; Poll suggests low public trust in US health institutions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ) US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ) Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. ( NBC ) Poll Finds Public Health Has A Trust Problem ( NPR ) ( RWJF ) Third ti...
  • RoundupsRoundups

    Euro Roundup: EMA streamlines processes to handle COVID-19 volume

    The European Medicines Agency (EMA) is temporarily revising its processes to cope with a rising volume of work related to the COVID-19 pandemic. EMA made the changes to ensure it can handle a “very active pipeline” that is expected to yield up to five COVID-19 therapies this year.   Faced with that workload, EMA is temporarily freeing co-rapporteurs from the need to provide their own assessment reports on initial marketing authorization applications for non-COVID-19 ...
  • Regulatory NewsRegulatory News

    Capacity adjustments, DMFs under discussion for GDUFA III

    Newly released minutes show progress made during the past two months of negotiations between the US Food and Drug Administration and industry on commitment language for the second reauthorization of the Generic Drug User Fee Amendments (GDUFA III).   In March and April, FDA and industry focused on a number of ongoing issues in seven negotiation meetings. (RELATED: Industry-FDA GDUFA III negotiations seek higher first-round approval rates , Regulatory Focus 11 Novemb...
  • Feature ArticlesFeature Articles

    EU MDR countdown: Readiness of medtech companies in Europe

    Around 75 days before the EU Medical Device Regulation’s May 2021 deadline, a survey was launched to evaluate EU-based medtech companies’ readiness for the impending changes. The findings showed that many manufacturers, particularly those with lower-risk devices, still feel unprepared for the new demands a year after the postponement. Notified bodies no longer seem to pose a major challenge, yet the regulation remains time- and cost-consuming, especially with regard to cli...
  • Regulatory NewsRegulatory News

    Euro Convergence: EU pediatric medicines regulatory framework needs simplification, optimization

    Industry would like to see some “pragmatic” changes to the regulatory process for pediatric medicines in the EU, according to a recent presentation at RAPS Euro Convergence 2021.   These changes include incorporating scientific discussion throughout a product’s life cycle, comparable reporting requirements for pediatric trials to those for adult trials, and optimization and simplification of pediatric investigation plan (PIP) procedures and compliance checks, said Thom...
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    RAPS' LatestRAPS' Latest

    RAPS Euro Convergence draws participants from 32 countries to hear from European regulatory experts

    RAPS Euro Convergence 2021 , the premier annual event for European regulatory professionals, wrapped up today after three days of online education sessions, expert presentations and panel discussions, and web-based professional networking opportunities.   Held virtually for the second year, the event drew 370 registrants from six continents and 32 countries. Over the course of 65 sessions, attendees heard from—and had the chance to connect with—168 expert speakers fro...