• Regulatory NewsRegulatory News

    FDA warns that some prenatal screening tests can generate false results

    Some non-invasive prenatal tests  (NIPT) to screen for genetic abnormalities in the fetus may generate false results, and should not be used for diagnostic purposes, the US Food and Drug Administration (FDA)  warned on Tuesday.   The growing – and sometimes inappropriate – use of these tests prompted the warning, according to FDA.   These tests, which fall under the category of laboratory-developed tests (LDTs), are not subject to premarket review by FDA and are ...
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    FDA outlines criteria for granting waivers for pH adjusters in generic drugs

    The US Food and Drug Administration (FDA) has issued a draft guidance on its criteria for permitting the use of pH adjusters in parenteral, ophthalmic or otic abbreviated new drug applications (ANDAs). FDA said in certain circumstances, certain differences in pH adjusters “may be scientifically appropriate and acceptable.”   This guidance outlines the process for requesting a waiver from complying with the generic drug regulations under §314.94(a)(9)(iii) and (iv). T...
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    FDA proposes to rate pharmaceutical manufacturing facilities

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality has proposed the development of a rating system to measure a firm’s quality management maturity (QMM)  as a way to mitigate drugs shortages and enhance the quality of finished drug products, according to a new white paper . The ratings would be publicly available.   “QMM ratings are a part of an evolution towards performance-based regulatory practice and, as such, they may raise concern for s...
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    Unannounced FDA inspections have started in India, not China

    The US Food and Drug Administration (FDA) unannounced foreign inspections program has resumed in India but is still paused in China due to local COVID-19 restrictions, Judith McMeekin, FDA associate commissioner for regulatory affairs, said on 6 April during a webinar sponsored by the Alliance for a Stronger FDA.   Members of Congress have expressed concern that FDA’s drug inspection program is inadequate to meet the meet the growth in foreign drug manufacturing facili...
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    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...
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    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...