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  • Regulatory NewsRegulatory News

    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
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    Lack of product-specific guidance slows ANDAs: FDA study

    Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue.   Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs.   In a retrospective study examining 400 br...
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    Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges

    The idea that regulatory agencies can come up with solutions in isolation is “very dangerous” and underscores the need for multi-stakeholder responses to emerging challenges, said Anthony Humphreys, of the European Medicines Agency (EMA), at the Euro Convergence 2020 virtual meeting.   Speaking during a session on supporting innovation, Humphreys, head of EMA’s regulatory science and innovation taskforce, set out the importance of gathering the views of other stakehold...
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    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...
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    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 ...
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    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...
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    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...
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    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...
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    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...
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    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(...
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    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...
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    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...