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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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    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
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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...
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    FDA Sends Form 483s to Lupin, Aurobindo and Cipla Sites

    Following inspections in late September, India-based generic drugmakers Lupin, Aurobindo and Cipla received Form 483s posted last week by the US Food and Drug Administration (FDA) for observations related to cleanliness, investigations into out-of-specification results and other deficiencies. Lupin’s site in Tarapur, India was inspected over five days in late September, and the partially redacted 483 includes three observations. The first questions the company’s investi...
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    FDA Explains Plans for New Pharmaceutical Quality Assessment System

    As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...
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    Do Biopharma Companies Really Spend More on Marketing Than R&D?

    As the drug pricing debate on Capitol Hill continues, the debate over how biopharma companies spend also continues. From 2014 through 2016, various publications—from the Washington Post to Vox to MedCity News —published an eye-opening chart showing that nine of the top 10 large pharmaceutical companies (all but Roche) spent more on marketing than research and development (R&D). The source of the chart is a 2014 BBC article , which relied on GlobalData, to...
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    Judge Blocks Pharma Prices in TV Ads Rule From Taking Effect

    US District Court Judge Amit Mehta late Monday ruled that the US Department of Health and Human Services (HHS) lacks the authority to require drugmakers to post list prices in pharmaceutical direct-to-consumer (DTC) television advertisements. The HHS rule, which was set to take effect on Tuesday and finalized in May , called for television advertisements for prescription drugs with a list price of $35 or more to contain a statement indicating the Wholesale Acquisition ...
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    MHRA Consults on Analytical Quality by Design Principles

    The UK’s Medicines and Health care products Regulatory Agency (MHRA) on Tuesday opened a three-month public consultation on its plans to apply analytical quality by design (AQbD) principles to its pharmacopoeial standards.   “Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasises product and process understanding and process control, based on sound science and quality risk management,” MHRA writes.   Th...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...