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  • RoundupsRoundups

    FDA Approvals Roundup: Vijoice, Hyftor, Yescarta

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Vijoice okayed for PIK3CA-related overgrowth spectrum Novartis’s Vijoice ( alpelisib ) has been granted accelerated approval for treating severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in adults and children aged 2 years or older who require systemic therapy.   This indication for Vijoice, a kinase inhibitor, was approved...
  • Regulatory NewsRegulatory News

    Cavazzoni discusses CDER staffing, FY2023 budget priorities

    The US Food and Drug Administration’s (FDA) budget request for FY2023 reflects a focus on combatting the nation’s opioid epidemic and improving postmarket surveillance, said Patrizia Cavazzoni, director of FDA’s Center for Drugs Evaluation and Research (CDER). Also, after a low attrition rate during the pandemic, vacancies are now trending upward as CDER staff is departing for new opportunities, she said on call with the Alliance for a Stronger FDA on Monday.   The FDA...
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    FDA Approvals Roundup: Pluvicto, Cabenuva, Fintepla

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Pluvicto approved for metastatic, castration-resistant prostate cancer Advanced Accelerator Applications’ Pluvicto ( lutetium [Lu 177] vipivotide tetraxetan; injection ) is approved as a radioligand therapy for metastatic castration-resistant prostate cancer in men who are positive for prostate-specific membrane antigen and have been treated wi...
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    Stakeholders want more clarity about devices used for remote clinical studies

    A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...
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    FDA Approvals Roundup: Ztalmy, Opdualag, Keytruda

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ztalmy gets go-ahead for rare form of genetic epilepsy in children, adults Marinus Pharmaceuticals’ Ztalmy ( ganaxolone; oral suspension ) has been approved for treating seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD), a rare form of genetic epilepsy, in patients aged 2 years or older.   Approval of Ztal...
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    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
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    FDA, EMA tout benefits of parallel scientific advice program

    Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages at a 16 March webinar held by FDA’s Small Business and Industry Assistance (SBIA) program.   The goal of the PSA program is to ...
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    FDA Approvals Roundup: Adlarity and Lynparza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Adlarity transdermal patch okayed for dementia in patients with Alzheimer’s disease Corium’s Adlarity ( donepezil; transdermal system ) has been approved for mild, moderate, or severe dementia in patients with Alzheimer's disease. The drug was approved via the 505(b)(2) pathway that allows drugs to be approved based in part on data from stud...
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    FDA resuming normalized operations but will continue to leverage MRAs

    As the US Food and Drug Administration (FDA) returns to normalized operations with onsite inspections, it will continue to take a risk-based approach in determining which firms are inspected next and continue to rely on mutual recognition agreements (MRAs) with other countries in assessing pharmaceutical facilities, according to Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operations on 1...
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    Quality metrics: FDA wants feedback on pared-down program

    The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.   The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unv...
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    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.   Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the ag...
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    FDA calls on firms to be ‘recall ready’ in final guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance to help regulated industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco.   The document addresses how firms should devise a recall communication plan and train personnel on executing a recall, as well as how companies should maintain distribution records and establish procedures for initia...