• ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
  • Regulatory NewsRegulatory News

    New USP chapter details lifecycle approach to analytical testing

    The United States Pharmacopoeia (USP) has released a new chapter 1220 ahead of publication in the USP-NF that sets a lifecycle approach to analytical method development with the goal of easing the process for instituting post-approval changes for analytical methods. The chapter will become official on 1 May 2022.   The USP chapter complements efforts underway at International Council for Harmonisation to develop a Q14 guideline to make it easier for manufacturers t...
  • Regulatory NewsRegulatory News

    FDA official breaks down novel excipient pilot program

    A new pilot program from the US Food and Drug Administration (FDA) dedicated to reviewing quality and toxicology data for novel drug excipients is aimed at speeding drug development by providing an easier pathway for the agency to qualify these ingredients.   “In some cases, FDA may find issues with the excipients used in a drug development application, which can affect and even delay the application,” explained FDA official Karen Davis Bruno, associate director of pha...
  • Regulatory NewsRegulatory News

    FDA’s accelerated approval program: Is change on the way?

    The U.S. Food and Drug Administration (FDA) launched its accelerated approval program in 1992, offering a pathway to bring life-saving drugs and biologics to the market faster. After nearly 30 years, could substantial reforms be on the way?   At RAPS Convergence 2021, David Dorsey of Janssen R&D, said Congress could choose to make changes to the accelerated approval program through the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Congress has...
  • 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. ...