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  • Regulatory NewsRegulatory News

    FDA Closes Zolgensma Data Manipulation Case Without Any Regulatory Action

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research on Tuesday said it has completed its review of Novartis’s data manipulation linked to its spinal muscular atrophy gene therapy Zolgensma (onasemnogene abeparvovec-xioi) and will not take regulatory action. Paul Richards, acting chief of CBER’s consumer affairs branch, told Focus : “FDA has completed its review of the inspection, the evidence collected, and the firm’s responses and ...
  • Regulatory NewsRegulatory News

    MHRA Blocks 135 Drugs From Parallel Export

    As drug shortage questions and increasing demands loom amid the coronvirus pandemic, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) this month added 135 medicines to its list of medicines that cannot be parallel exported from the UK. Parallel exporting means buying medicines already on the market in the UK and selling them in another country in the European Economic Area. Beginning on 13 March, MHRA added hydroxychloroquine, a possible COVID-19 t...
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    FDA Warns Pfizer Manufacturing Site in India

    Following an inspection last August and September, the US Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India. The letter, dated 25 March and released Tuesday, explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing. FDA also notes microbial contamination and how the site “did ...
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    What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of Commercial Tests

    As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per day, many observers, including the US Food and Drug Administration (FDA) are looking back at the last two months wondering what took so long to get to this point. A front-page article in Sunday’s New York Times explained how the virus spread for weeks without any testing, with experts pointing to early problems with the CDC’s first...
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    FDA Eases Regulatory Requirements on Surgical Gowns, Gloves

    As the number of COVID-19 cases increase in the US and hospitals struggle with keeping their doctors and nurses protected, the Food and Drug Administration (FDA) on Monday released guidance explaining how it will relax certain regulatory requirements to increase the production and availability of certain personal protective equipment (PPE) such as gowns and gloves.  As early as late February, FDA began warning of PPE shortages, and hospitals in areas hit hard by the c...
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    FDA EUA Allows States to Receive Unapproved COVID-19 Treatments

    Opening the door to the wider use of unapproved but potential COVID-19 treatments, the US Food and Drug Administration (FDA) late Sunday issued an emergency use authorization (EUA) to allow the US Biomedical Advanced Research and Development Authority (BARDA) to distribute donated hydroxychloroquine sulfate and chloroquine phosphate products to doctors, who can decide whether to prescribe them to hospitalized teen and adult patients with COVID-19 when a clinical trial is n...
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    Notifying FDA of Drug Shortages During the Pandemic: FDA Offers Guidance

    With an eye on drug supply disruptions, the US Food and Drug Administration (FDA) on Friday published new guidance on how manufacturers should notify FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply. An FDA spokesman told Focus that so far, only one firm is reporting a shortage of one human drug. FDA previously declined to name the firm or the drug, citing confidential commercial i...
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    EMA Signs Off on Conditional Authorization for Novartis Gene Therapy

    The European Medicines Agency’s Committee for Advanced Therapies on Friday announced that it has recommended a conditional authorization for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) as a treatment for babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease. EMA’s recommendation is based on the preliminary results of one completed clinical trial and three supporting studies in patients with SMA with differ...
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    FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

    As there are still no approved treatments for COVID-19, the US Food and Drug Administration (FDA) this week warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19. The warning letter, released publicly on Friday, follows the distribution of warning letters to seven companies for making fraudulent and unsupported claims about products,...
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    FDA Ends CSR Pilot, Plots New Approach for Disclosing Study Reports

    The US Food and Drug Administration (FDA) on Thursday officially ended a fledgling pilot program that was part of an effort to provide more transparency on the drug approval process. The agency said it’s working on a new approach to disclosing study reports. Last June, the agency was already pushing away from the clinical study report (CSR) pilot because of lackluster participation (FDA noted that  Janssen was the only sponsor  that agreed to participate) and said it wo...
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    European Commission Adopts Revised Standards to Speed Devices to Market

    As part of work to facilitate a faster and less expensive conformity assessment procedure for those marketing certain medical devices, the European Commission earlier this week adopted revised harmonized standards. The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous in...
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    Coronavirus Relief Bill Includes OTC Drug User Fee Program

    A wide-ranging $2 trillion coronavirus emergency relief bill is expected to become law tomorrow and included in it are provisions not only related to drug and medical device shortages and COVID-19 testing, but also a new user fee system for over-the-counter (OTC) drugs. Overall, the bill is meant to provide relief to the struggling economy and to help government agencies and health facilities as more than 70,000 in the US now have COVID-19 and as the rate of new infecti...