• Regulatory NewsRegulatory News

    EMA proposes quality guidelines for synthetic peptides and oligonucleotides

    The European Medicines Agency (EMA) want to set clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides.   EMA raised the idea of specific guidelines for such products in new concept papers published this week, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.   According to the agency, the p...
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    Industry seeks clarity on FDA’s standards recognition process for regenerative medicines

    Commenters on a recent draft guidance released by the US Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER) support the idea of creating a voluntary consensus standards (VCS) recognition program for regenerative medicine therapies (RMTs) but want more details from the agency on the types of VCS recognized and the process for engaging FDA through the program.   As the RMT product scientific and manufacturing landscape evolves, recog...
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    Califf: FDA committed to boosting complex generic drug development

    Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase its early interactions with industry to promote more first-cycle approvals of complex generics at a 20 September webinar sponsored by FDA’s Small Business and Industry Assistance (SBIA) program.   The workshop, entitled “Advancing Generic Drug Development: Translating Science to Approval” focused on common deficiencies i...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA seeks feedback to reduce paracetamol poisoning

    Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into ways to reduce the risk of paracetamol poisoning, based on and independent review that found “a concerning increase of misuse in the community.”   TGA commissioned the report in response to the rising prevalence of intentional paracetamol poisoning, especially among young people, involving paracetamol purchased without the oversight of a pharmacist in supermarkets and convenience stores. ...
  • ReconRecon

    Recon: FDA staff raise concerns over Spectrum’s cancer drug ahead of adcomm; EMA calls for biosimilar interchangeability in EU

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US drug regulator resumes surprise inspections in India ( Economic Times ) Merck to start studying lower dose of HIV drug after FDA hold ( Reuters ) Adderall Shortages in US Spread to Two More Drug Suppliers ( Bloomberg ) Negotiations over legislation to reauthorize the FDA’s user fee programs continue into this week ( Politico ) House Democrat presses bill t...
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    Convergence: Global landscape evolves on real-world evidence, but at an uneven pace

    PHOENIX, AZ – Real-world evidence (RWE) is gaining a foothold as an important part of regulatory decision making but health authorities around the world are at different stages of acceptance and policy development.   “We do expect [real-world data] and RWE to play an increasing role in drug development and regulatory decision making,” Seema Betigeri, PhD, Executive Director of Global Regulatory Affairs at Merck, said at RAPS Convergence 2022. She noted that the United ...
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    MDCG offers guidance on ‘appropriate surveillance’ under IVDR transition period

    The European Commission’s Medical Devices Coordination Group (MDCG) last week issued guidance offering in vitro diagnostic makers and notified bodies clarity on what constitutes “appropriate surveillance” of diagnostics during the In Vitro Diagnostic Medical Devices Regulation (IVDR) transition period.   “Devices which are covered by valid certificates issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) may be plac...
  • Feature ArticlesFeature Articles

    Global overview for probiotics: Trends, markets, and harmonization

    This article discusses current diverging regulations for probiotics as ingredients in foods and dietary supplements and the trends and translational science that have demonstrated probiotic benefits. It emphasizes how aligning a global probiotic harmonized regulatory framework can help navigate the confusion around the regulations to ensure global consumer access to beneficial products of quality.   Keywords – Codex, harmonization, regulations, probiotics, probioti...
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    CDER official reflects on a decade of patient-focused drug development

    Multistakeholder meetings held as part of US Food and Drug Administration (FDA) patient-focused drug development efforts have left a huge impact on everyone involved, according to Theresa Mullin, PhD, associate director for strategic initiatives within the FDA Center for Drug Evaluation and Research (CDER).   Mullin, who leads the Patient-Focused Drug Development (PFDD) program at FDA, told attendees at a recent webinar hosted by the Alliance for a Stronger FDA tha...
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    CHMP recommends 12 new medicines, including first RSV treatment for infants

    The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.   The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was s...
  • ReconRecon

    Recon: FDA give thumbs-up to bluebird bio’s gene therapy treatment for rare neurological disorder; EMA OKs RSV preventive

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA approves bluebird bio's gene therapy for a rare neurological disorder ( Reuters ) ( Biospace ) Heron scores FDA go-ahead for Aponvie, an IV alternative to pills for postoperative nausea ( Fierce ) FDA Action Alert: Regeneron, Spectrum and More ( Biospace ) Amylyx’s ALS Pledge Vs. FDA’s Obscure Withdrawal Authority: Which Holds More Power? ( Pink Sheet...
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    Convergence: Understanding expedited approval pathways in Japan

    PHOENIX, AZ -- There are five pathways for expedited approval of novel drugs in Japan, but advanced planning is essential, according to Mark Lane, PhD, of PharmaLex.   “You really have to plan your entry into Japan early. If you wait until you’re in Phase 2 to start thinking about what you’re going to do in Japan, the chances that you’ll be able to join in your global program get less and less,” said Lane, vice president of development and scientific affairs at PharmaL...