• Regulatory NewsRegulatory News

    FDA proposes rule broadening nonprescription drug access for consumers

    The US Food and Drug Administration (FDA) has issued a new proposed rule that would allow drug companies to add conditions for consumers to access nonprescription drug products.   A limitation of current nonprescription drug labeling is that it doesn’t always adequately communicate the information consumers need to self-select a product on their own. FDA said the goal of the proposed rule is to increase access to new nonprescription drugs where drug labeling alone is i...
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    FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs

    The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...
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    COVID-19 vaccine tracker

    In March 2020, the Regulatory Focus editorial team was eager to find a way to meet the information needs of RAPS members and the regulatory community as the reality of a coronavirus pandemic set in. Guided by the RAPS Editorial Advisory Committee, the first iteration of this tracker was published on 21 March 2020.    What started as a running list containing one Phase I vaccine candidate (now known as Moderna’s Spikevax) and scores of preclinical possibilities evol...
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    FDA prevented record number of drug shortages in 2021

    The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.   The agency’s Center for Drug Evaluation and Research (CDER) has been tracking drug shortages since the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires FDA to release an annual report to Congress; FDA’s Center f...
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    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
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    VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children

    On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...
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    VRBPAC unanimously backs Moderna vaccine for children 6 and up

    The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...
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    Study: FDA approves new oncology drugs quicker than EMA

    The US Food and Drug Administration (FDA) is quicker to approve new oncology drugs compared with the European Medicines Agency (EMA), according to a study published 10 June in JAMA Network Open .   Mark P. Lythgoe, MBBS, of Imperial College London, and colleagues performed a cross-sectional study of 89 oncology drugs that were approved in the US and Europe between 2010 and 2019, analyzing how long each drug was reviewed, when the drug was submitted for marketing autho...
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    Expert proposes changes to accelerated approval reforms in user fee bills

    With the Senate Committee on Health, Education, Labor and Pensions (HELP) recently releasing the Food and Drug Administration Safety and Landmark Advancements (FDASLA) act from committee, some stakeholders are proposing Congress make changes to the user fee authorization bill to address issues with the US Food and Drug Administration’s (FDA) accelerated approval pathway.   While some of the accelerated approval reforms in the House and Senate user fee billl are simil...
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    Study: Breakthrough designated drugs led to better clinical outcomes for patients with NSCLC

    Drugs granted a breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) were more likely to yield better outcomes for patients with non-small cell lung cancer (NSCLC) compared with drugs that didn’t carry the designation, according to a recent analysis published in Clinical Cancer Research .   “Our findings show that the criteria for a breakthrough therapy designation are identifying products that provide maximum benefits for patients,” Jef...
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    House GOP reps question FDA commissioner on drugs with China-only data, trial site inspections

    Republicans in the House Committee on Energy and Commerce have sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf asking him to provide information about drugs approved solely based on data from clinical trials conducted in China and details about FDA trial site inspections in China. In their letter, Reps. Cathy McMorris Rodgers (R-WA), Brett Guthrie (R-FL), and H. Morgan Griffith (R-VA), said they are concerned about an increase of FDA dr...
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    Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation

    Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a new formulation, while other factors like clinical effectiveness were not predictive of reformulation, according to a recent study published in JAMA Health Forum .   “This study reinforces concerns that manufacturers are using evergreening strategies to maintain revenue and avoid generic competition,” Ravi Gupt...