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  • Regulatory NewsRegulatory News

    FDA clarifies reference-listed drugs, other ANDA terms in final guidance

    Generic drugmakers have received finalized guidance from the US Food and Drug Administration. In finalizing a 2017 draft, the agency gives sponsors of abbreviated new drug applications (ANDAs) information about how to identify reference listed drugs (RLDs), further details on reference standards, and what forms the basis for an ANDA submission.   “The guidance is intended to clarify what these terms mean and how to accurately use these terms in an ANDA,” said FDA in an...
  • Regulatory NewsRegulatory News

    Euro Convergence: Suboptimal use of MDR grace period is storing up trouble

    Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity constraints and tight deadlines, according to experts who spoke at the Euro Convergence 2020 virtual meeting.   In November last year, the European Commission issued a corrigendum to the MDR, allowing manufacturers of certain class I products an additional four years, to 26 May 2024, to comply with the regulation. Unde...
  • ReconRecon

    Recon: Exact Sciences nabs rival Thrive for $2B+; Lilly's COVID antibody flops

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Third wave of coronavirus infections in the U.S.? More like 'wildfire,' epidemiologist says ( NBC ) U.S. Coronavirus Cases Surpass Summer Peak And Are Climbing Higher Fast ( NPR ) Covid hospitalizations rising in 36 states as U.S. hits another record for average new cases ( CNBC ) Fauci on latest surge: 'No matter how you look at it, it's not good news' ( The ...
  • Asia-Pacific Roundup: India delays stronger ultrasound regs by a year

    Manufacturers of ultrasound equipment now have until the start of November 2021 to comply with an Indian government plan to regulate their products as drugs.   In October 2019, the Indian government outlined plans to start regulating ultrasound equipment as drugs from November 2020 onward, thereby giving the Central Drugs Standard Control Organization (CDSCO) more power to oversee production and sale of the devices. The timeline put ultrasound in the middle of the br...
  • Regulatory NewsRegulatory News

    Euro Convergence: Looming deadlines, regulatory bottlenecks keep EU officials up at night

    The opening plenary session of the Euro Convergence 2020 virtual meeting brought together regulatory professionals from industry, notified bodies and competent authorities. The virtual format, said co-chair  Gert Bos, FRAPS of the Netherlands’ Qserve Group, meant that it was possible to draw together a record 14 individuals for the session.   Co-chair Sabina Hoekstra-van den Bosch, PharmD, FRAPS, asked session participants what is keeping them up at night in 2020, espe...
  • Regulatory NewsRegulatory News

    FDA delays enforcement of some DSCSA provisions by three years

    The US Food and Drug Administration (FDA) last week announced it will again delay enforcement of a provision of the Drug Supply Chain Security Act (DSCSA) that would require wholesalers to verify saleable returned drugs they intend to further distribute.   “FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2023, verify the product identifier prior to further distributing returned product as required under section 582(...
  • FDA-state compounding MOU now available for signing

    A standard memorandum of understanding between the US Food and Drug Administration (FDA) and the states regarding interstate distribution of compounded drugs is available for signing.   State boards of pharmacy or other state agencies have 365 days to sign the document. After that time, FDA intends to begin enforcing a provision of the Federal Food, Drug and Cosmetic Act (FD&C Act) that prohibits states that have not signed the MOU from distributing more than 5% of a c...
  • ReconRecon

    Recon: FDA delays decision on Spectrum drug due to COVID travel restrictions; Bayer to buy AskBio for up to $4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA delays decision on Spectrum Pharma's drug candidate due to travel curbs ( Reuters ) ( Endpoints ) Two Companies Restart Virus Trials in U.S. After Safety Pauses ( NYTimes ) ( FT ) South Korea pharma Celltrion's COVID test gets US emergency use authorisation ( Reuters ) U.S. disease expert Fauci says vaccine verdict due by early December ( Reuters ) Senate...
  • Regulatory NewsRegulatory News

    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...
  • Regulatory NewsRegulatory News

    Breast implant-lymphoma link probed by EC committee

    The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.   The EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued on report on the relationship between breast implants and anaplastic large cell lymphoma (BIA-ALCL). The committee’s charge encompassed use of implants both for breast reconstru...
  • Regulatory NewsRegulatory News

    EMA highlights multiple considerations when developing drugs for older adults

    In a recently released reflection paper, the European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. But the sole focus should not be on chronological age since patients of any age may experience similar needs or impairments. “For example, the need for an easy to ...
  • ReconRecon

    Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Facing vaccine doubts, US grapples with building confidence in coronavirus shots ( BioPharma Dive ) FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines ( STAT ) How pandemic fatigue and polarization led to Wisconsin’s massive Covid-19 outbreak ( Vox ) ( NPR ) Report finds coronavirus pandemic leading to 'unacceptable' shortage of US ...