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  • Regulatory NewsRegulatory News

    FDA drug review times reflective of 4 key features, GAO finds

    The length of review of new drug applications (NDAs) by the US Food and Drug Administration’s (FDA) divisions is generally contingent on four features of the application, according to the Government Accountability Office’s (GAO) analysis of 637 original NDAs submitted from fiscal years 2014 through 2018. Overall, GAO found that the four key features are: 1. Whether the NDA qualifies for a priority review, which is four months less than for an otherwise standard, 10-m...
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    Hospitals report ‘severe shortages’ of COVID-19 tests, HHS survey finds

    The US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) on Monday released the results of telephone survey of 323 hospitals across 46 states, the District of Columbia and Puerto Rico, finding “severe shortages of testing supplies and extended waits for test results.”    Hospitals reported that they were unable to keep up with COVID-19 testing demands because they lacked complete kits and/or the individual components and supplies needed t...
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    3M questions Trump order to halt respirator exports

    The Trump Administration on Thursday formally invoked the Defense Production Act (DPA) to require 3M to prioritize orders from the Federal Emergency Management Agency for N95 respirator masks and requested that the firm cease exporting respirators to Canada and Latin America. Trump tweeted late Thursday: “We hit 3M hard today after seeing what they were doing with their Masks. ‘P Act’ all the way. Big surprise to many in government as to what they were doing - will ...
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    European Commission proposes to delay MDR by a year due to COVID-19

    The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May. The European Parliament is expected to vote on the proposal on 16 April. With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, ...
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    Why FDA’s Issuance of EUAs are not ‘approvals’ and why that matters

    You may have read that some drugs are now “approved” to treat COVID-19, or as the New York Times reported yesterday, that the US Food and Drug Administration (FDA)  “approved” the first serology test for COVID-19, or that the dozens of marketed COVID-19 diagnostics are “approved” by FDA. But in reality, FDA still has not approved any treatment or test for COVID-19 and has instead issued what are known as emergency use authorizations, or EUAs. From an outsider’s persp...
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    FDA issues first EUA for coronavirus serology test

    In a move that could help the US better understand who has already had COVID-19, the US Food and Drug Administration (FDA) on Thursday provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc. The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) that are generated as part of the human immune response to the virus. Although FDA recommends that results from serology testing should n...
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    FDA reports shortage of sedation drug used for putting COVID-19 patients on ventilators

    The US Food and Drug Administration (FDA) on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation. The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what's to come for other sedation drugs too. Michael Ganio, senior director of pharmacy practice and quality at the...
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    CDRH warns 5 device firms in US, China, Hungary, Thailand and Taiwan

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently released five warning letters sent to medical device manufacturers around the globe due to various violations. The release comes as device warning letters plunged nearly 90% over five years and as CDRH only issued nine warning letters in all of 2019. US For Nevada-based Steiner Biotechnology, an investigator from FDA’s Office of Bioresearch Monitoring Operation...
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    FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns

    The US Food and Drug Administration (FDA) on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures. The announcement is the most serious in a chain of FDA safety advisories related to NDMA ...
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    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 ...
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    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 ...