• Regulatory NewsRegulatory News

    OPDP plans more research on presentation of 'targeted' MoAs

    The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) this week proposed new research intended provide insights on how claims, graphics and disclosures about targeted mechanisms of action (MoA) influence consumer and health care provider (HCP) perceptions.   OPDP said it is particularly interested in finding out how different presentations of MoA affect consumers’ and HCPs’ understanding of a drug's MoA, its benefits and risks, attent...
  • Regulatory NewsRegulatory News

    ICH Q12 guideline draws more comments from industry

    A major pharmaceutical industry group is calling for the US Food and Drug Administration (FDA) to institute several revisions to the International Council for Harmonization’s (ICH) Q12 guideline on postapproval changes.   The document was released by FDA for public feedback in May. (RELATED: ICH Q12: FDA guidance explains US implementation, Regulatory Focus , 21 May 2021).   The International Society for Pharmaceutical Engineering (ISPE) suggested in its 8 Oct...
  • RoundupsRoundups

    Approvals Roundup: Xipere, Seglentis, Dupixent

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xipere okayed for uveitis-associated macular edema Clearside’s  Xipere (triamcinolone acetonide injectable suspension) has been approved for use in the  suprachoroidal space of the eye to treat macular edema associated with non-infectious uveitis.   The approval of the corticosteroid was based on findings from the Phase 3 randomized, mul...
  • ReconRecon

    Recon: Merck signs royalty-free deal with Medicines Patent Pool for molnupiravir; Cortexyme's Alzheimer's candidate misses primary endpoint

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cortexyme's Alzheimer's treatment fails to meet main goals in study ( Reuters ) ( STAT ) Democratic senators raise concerns with potential FDA pick ( STAT ) This May Be Democrats’ Best Chance to Lower Drug Prices ( NYTimes ) Pharma Campaign Cash Delivered to Key Lawmakers With Surgical Precision ( KHN ) Democrats pitch industry-friendly Medicaid workaround to...
  • Regulatory NewsRegulatory News

    Regulators release 10 principles for good machine learning practice

    Regulators from the US, Canada, and the United Kingdom unveiled 10 principles to guide the development of good machine learning practice for medical devices.   The principles are meant to be used to drive the adoption of good practices that have been proven in other sectors, to help tailor those practices so that they are applicable to medical technology, and to create new practices specific to the health care sector. The document, which was issued by the US Food and...
  • Feature ArticlesFeature Articles

    EU regulation of medicinal products, medical devices, and food supplements: A comparative perspective

    This article compares and contrasts the regulatory requirements for herbal medicinal products, herbal-based medical devices, and botanical food supplements in the EU. It provides an overview of the current framework, highlights areas of controversy, and presents recent regulatory developments. The article is the first of two on this topic. The current article presents the definitions, main regulations, and documentation requirements for placing the products on the market; ...
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    Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids

    Younger school-aged children in the US came a step closer on Tuesday to having a COVID-19 vaccine available, with a positive vote from the US Food and Drug Administration's (FDA's) vaccines advisory committee for a reduced dose of Pfizer’s mRNA vaccine.   The vote was near-unanimous, with just one abstention and no “nays” among the 18 voting members of FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC). Overall, the committee judged that the ben...
  • Regulatory NewsRegulatory News

    European Commission identifies 10 ‘promising’ COVID treatments

    The European Commission (EC) on 22 October released a list of the 10 “most promising treatments” for COVID-19 as part of its strategy to support the development of new therapies.   A panel of scientific experts selected the 10 drugs from a pool of 82 therapeutic candidates that are in late-stage clinical development.    “In selecting the 10 most promising candidates, experts focused on the product categories with the highest potential impact on the pandemic: produc...
  • Regulatory NewsRegulatory News

    CDRH outlines guidance plans for FY2022

    The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released its list of guidances it intends to issue or finalize in FY2022, with new guidances planned and some documents making repeat appearances from last year's list.   As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft and final guidances, which CDRH says it will publish as res...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA mulls mandating medical device adverse event reporting by healthcare facilities

    Australia's Therapeutic Goods Administration (TGA) is seeking feedback on plans to make it mandatory for healthcare facilities to report adverse events linked to medical devices. Currently, only manufacturers and sponsors need to report adverse events, and TGA is concerned that longer-term device failures, such as those involving urogynaecological mesh, may present in different healthcare settings to the original procedure.   The consultation grew out of an investigati...
  • ReconRecon

    Recon: WHO review of India's Covaxin underway; Novartis mulls spinoff of generic unit Sandoz

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children ( Reuters ) Becton Dickinson begins selling new at-home rapid COVID-19 test ( Reuters ) Latest psilocybin patent highlights the swirling battle over psychedelics intellectual property ( STAT ) US will require foreign travellers to get WHO-authorised vaccines ( FT ) NIH enlisted to help FDA assess...
  • Regulatory NewsRegulatory News

    FDA encourages industry to adopt modeling tools to ensure stable processes

    An official with the US Food and Drug Administration (FDA) encouraged the pharmaceutical industry to adopt advanced process control (APC) modeling tools to ensure that manufacturing processes are operating in a state of control, asserting that these processes are often reactively monitored rather than proactively controlled.   “Our process capabilities remain at two or three sigma, because we are relying on manufacturing of the last century,” said Stelios Tsinontides, ...