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  • Regulatory NewsRegulatory News

    Euro Convergence: Early consultation critical in overcoming gene therapy hurdles

    When it comes to advancing gene therapy products in the United States and Europe, the key is early consultation with regulators and identification of potential problems, experts said at the Euro Convergence 2020 virtual meeting. “It is better to do it earlier and establish a collaborative and educational approach to discussions,” advised Mridula Shukla, director of global regulatory affairs at Arcutis Biotherapeutics in Palo Alto, Calif.   Patrick Celis, PhD, head of ...
  • Regulatory NewsRegulatory News

    FDA revises REMS MAPP for new comparable ETASU provisions

    The US Food and Drug Administration (FDA) this week revised its manual of policies and procedures (MAPP) to reflect recent statutory changes that make it easier for drugmakers to develop separate risk evaluation and mitigation strategies (REMS) with comparable elements to assure safe use (ETASU).   The Further Consolidated Appropriations Act, 2020 , which was enacted late last year, included two provisions aimed at increasing generic and biosimilar competition.   ...
  • 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 ...
  • Regulatory NewsRegulatory News

    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...
  • 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...
  • 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...
  • 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 ...
  • 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...
  • 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...
  • 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 ...