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  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Pragmatic approaches to data collection needed to meet MDR

    Manufacturers have a narrowing window of opportunity during which to find pragmatic ways for gathering post-market data to support continued use of products under the Medical Device Regulation (MDR), according to experts who spoke at the Euro Convergence 2020 virtual meeting.   The outgoing Medical Device Directive (MDD) contains scant information on post-market surveillance (PMS) and post-market clinical follow-up (PMCF). MDD contains two uses of the term PMS, creatin...
  • Regulatory NewsRegulatory News

    EMA rolls out implementation plan to address nitrosamine impurities

    The European Medicines Agency (EMA) has rolled out its full plan to implement recommendations to reduce the risk that medicines will be contaminated with nitrosamine impurities, identifying short-, medium- and long-range priorities. The agency has also made templates available for marketing authorization holders to perform risk assessment and confirmatory testing.   The implementation plan builds out a framework for putting in place the specific recommendations of a ...
  • RoundupsRoundups

    FDA Approvals Roundup: Remdesivir, Eysuvis, Sklice

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Remdesivir gets the go-ahead for COVID-19 Gilead Sciences’ Veklury (remdesivir) has been approved for the treatment of older children and adults who are hospitalized with COVID-19. [SEE: Remdesivir receives FDA approval for COVID-19 , Regulatory Focus , 22 October 2020]   New indications Eysuvis okayed for short-term treatment of dry e...
  • ReconRecon

    Recon: Sanofi, GSK to supply 200M vaccine doses to COVAX scheme; US strikes deal for Lilly’s COVID antibody drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer CEO All but Rules Out Vaccine Before Election Day ( NYTimes ) ( FT ) US strikes deal with Lilly for potential COVID-19 antibody drug ( Reuters ) ( Endpoints ) ( Press ) Lawmakers release trove of Purdue documents detailing Sackler family’s involvement in opioid sales ( STAT ) I'm the FDA point person on COVID-19 vaccines. We'll make sure they're safe an...
  • Regulatory NewsRegulatory News

    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...
  • 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(...