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    FDA reports more shortages of drugs used to put COVID-19 patients on ventilators

    Increasing demand for sedatives used to help put COVID-19 patients onto ventilators means the US Food and Drug Administration (FDA) added two more – this time the injectables propofol and dexmedetomidine – to its list of drug shortages. The propofol shortage was also previously listed by the American Society for Health-System Pharmacists (ASHP) earlier this month, with manufacturers noting increased demand. Michael Ganio, senior director of pharmacy practice and quali...
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    FDA offers guidance for generic drug developers of hydroxychloroquine, chloroquine

    The US Food and Drug Administration (FDA) on Monday issued two new product-specific guidance documents for the unproven but highly demanded potential COVID-19 drugs chloroquine phosphate and hydroxychloroquine sulfate. The two generic drugs, approved by FDA as malaria drugs, have been touted by President Donald Trump in press conferences during the pandemic, but clinical trial data regarding their efficacy for COVID-19 remain thin. Regardless, 30 million doses of hyd...
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    Compounding drugs during the pandemic: FDA offers policy clarifications

    In response to “many emails from stakeholders,” the US Food and Drug Administration (FDA) late Monday clarified a few policies related to drug compounding, including one on the limit on the interstate distribution of compounded drug products for pharmacy compounders. Overall, FDA said its policies are meant to protect patients from unsafe, ineffective and poor-quality compounded drugs while preserving access for patients. In one of the updates, FDA clarifies that a ...
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    New system to speed industry-EMA interactions on drug shortages

    The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...
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    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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    EMA advises on compassionate use programs for remdesivir

    The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...
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    PDUFA, BsUFA resource capacity planning: Report recommends refinements

    A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.   Background   A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regul...
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    Hear from the experts who wrote the book

    RAPS has introduced a new, comprehensive resource that promises to find a secure place on every regulatory professional’s bookshelf. Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition , spans 18 chapters with updates from more than 30 leading regulatory experts. Topics range from why it is no longer enough for today’s regulatory professional to just focus on regulatory guidance, to a primer on regulatory intelligence, to defining regulatory strategies...
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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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    Clinical trials during COVID-19: Updates from FDA, MHRA and TGA

    The US Food and Drug Administration (FDA) last week updated its guidance from earlier this month on conducting clinical trials during the coronavirus disease (COVID-19) pandemic.   The update comes as other regulatory authorities offer updates on managing new or ongoing clinical trials during the outbreak and as pharma companies have begun to halt or alter ongoing trials. Both European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulator...
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    EMA limits use of malaria drugs for COVID-19 as FDA reports shortages

    Two drugs primarily used to treat malaria, chloroquine and hydroxychloroquine, should not be used to treat coronavirus disease (COVID-19) outside of clinical trials or emergency use programs, the European Medicines Agency (EMA) said Wednesday.   The agency said there is currently no evidence for the drugs’ efficacy in treating COVID-19 and warns that both drugs can have serious side effects.   “They must not be used without a prescription and without supervision by...
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    Public Funds Help Late-Stage Development of About 25% of New Drugs, Study Finds

    One in four new drugs approved in the US between January 2008 and December 2017 received direct funding from public resources for late stage research or through spin-off companies created from public research institutions, a study published in the BMJ on Wednesday found.  As the drug pricing debate has accelerated in recent months, the debate over whether public or private entities do the majority of drug development work has continued, with the general assumption tha...