• ReconRecon

    Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck seeks first U.S. authorization for COVID-19 pill ( Reuters ) Roche says Alzheimer's therapy gets U.S. breakthrough designation ( Reuters ) U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month ( Reuters ) Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA ( Reuters ) Adamas, Flexion sell for $825M combined as de...
  • Regulatory NewsRegulatory News

    EMA readies CTIS go-live plan

    A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.   The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed ...
  • Regulatory NewsRegulatory News

    ICH guideline proposes daily limits for seven mutagenic impurities

    The International Council for Harmonization (ICH) on Wednesday issued its M7(R2) guideline setting new permitted daily exposure (PDE) limits for seven DNA-reactive substances to limit their carcinogenic risk. The guideline is now available for public comment.   The guideline contains 21 mutagenic impurities, adding seven substances to the 14 previously published in the ICH M7(R1) guideline, which reached Step 4 in June 2017. (RELATED:   FDA Finalizes Guidance on Mut...
  • Regulatory NewsRegulatory News

    Pharma group decries EU’s ‘fragmented’ system for GMO-containing medicines

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) is calling for greater harmonization of genetically modified organism (GMO) procedures for investigational medicinal products, saying the complex process has the potential to slow the initiation of clinical trials for advanced and cellular therapies.   In a perspective article in Cell & Gene Therapy Insights and a related press release, EFPIA said the current system is more restrictive than...
  • ReconRecon

    Recon: EU says Russia delayed EMA Sputnik V inspections; FDA approves ChemoCentryx's Tavneos for rare autoimmune disease

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's biomedical research agency dropped from social spending bill ( Politico ) ChemoCentryx's drug gets US FDA nod for treating rare autoimmune disease ( Reuters ) FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus ( Endpoints ) Newly revealed texts from ex-FDA leader Stephen Hahn offer behind-the-scene glimpse in...
  • 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.   Regulators around the world have allowed a handful of treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab; Regeneron’s casirivimab and imdevim...
  • Regulatory NewsRegulatory News

    FDA reclassifies surgical staplers, staples after review links devices to injuries and deaths

    The US Food and Drug Administration (FDA) on Thursday reclassified surgical staplers and staples for internal use from Class I (general controls) to the more stringent Class II (special controls) after a 2019 review of adverse events linked the devices to reports of hundreds of deaths and thousands of injuries.   With the final reclassification order in place, surgical staplers for internal use must now undergo premarket review and will be subject to special controls b...
  • Regulatory NewsRegulatory News

    FDA recognizes Memorial Sloan Kettering tumor variant database

    The first somatic human variant database has been recognized by the US Food and Drug Administration for inclusion in its Public Human Genetic Variant Database listing. The move opens the door for developers of tumor profiling tests to use the database to support clinical validity claims in regulatory submissions.   A portion of Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OnkoKB) received the recognition under FDA’s database recognition program. ...
  • Regulatory NewsRegulatory News

    ICH announces sign-off on good clinical practices guideline

    The International Council for Harmonization (ICH) recently announced that the E8(R1) guideline on general considerations for clinical studies had reached Step 4 and is awaiting sign-off by regulators. The widely anticipated guideline modernizes the design, conduct and reporting of clinical trials by adopting quality by design principles. The guideline incorporates “current concepts achieving fit-for-purpose data quality.”   ICH announced that “the modernisation of IC...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Diversity in regulatory affairs, clinical trials, and more

    Feature articles during September focused on diversity in regulatory affairs, challenges in conducting medical device clinical trials in Europe, clinical trial regulation and laws in China, and risk management in working with third-party distributors.   Equity in action, diversity, and resilience In Fall 2020, representatives from Pfizer Global Regulatory Affairs (GRA) and the Howard University College of Pharmacy (HUCOP) initiated discussions about creating a care...
  • RoundupsRoundups

    Euro Roundup: PRAC starts reviewing risk of tumors linked to women’s health products

    The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has started reviewing the risk of tumors linked to women’s health products that contain nomegestrol or chlormadinone. PRAC opened the review in response to cases of non-malignant tumors of the brain and spinal cord.   Nomegestrol or chlormadinone are used in products that treat gynecological disorders, such as uterine bleeding, and as hormone replacement therapies or contraceptives...
  • ReconRecon

    Recon: Pfizer, BioNTech request vaccine EUA for children 5-11; Moderna plans African vaccine manufacturing site

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer vaccine for children may be ready by Thanksgiving -White House adviser ( Reuters ) Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11 ( Reuters ) ( WSJ ) ( Politico ) Tensions grow between Moderna, White House over vaccine production ( Politico ) Moderna Wants Fed. Cir. Help to Avoid Covid Vaccine Patent Suits ( Bloomberg ) Biden c...