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    FDA Singles Out Three Drug Substances to Not be Compounded

    The US Food and Drug Administration (FDA) on Monday identified three bulk drug substances that it is proposing to not include in a list of such substances for which there is a clinical need (known as the 503B bulks list). Bumetanide, nicardipine hydrochloride and vasopressin are the three bulk drug substances that FDA has considered and is proposing not to include on the list, as they can be obtained through already approved products. The nominations for these three act...
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    Six Asian Firms Blocked for Refusing FDA Inspections

    Four Chinese, one Indian and one South Korea-based drug manufacturer have been added to the US Food and Drug Administration’s (FDA) import alert list in August for failing to allow inspections. A company’s addition to what’s known as the “red list” means that they can no longer ship product to the US. As FDA explains, “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined with other evidence, prov...
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    Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on Assessment of Pressor Effects

    Companies took issue with specific elements of the draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure. Roche/Genentech explained, “While we agree with the spirit of the draft guidance with respect to ambulatory blood pressure monitoring (ABPM), we believe that a risk-based approach would better address the concern of potential drug-induced effects on blood pressure (BP) by reserving ABPM investigations ‘for cause’ (e.g.,...
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    Drug Prices in Ads: Senate Passes Amendment

    The Senate spending bill passed Thursday and with it an amendment from Sens. Richard Durbin (D-IL) and Chuck Grassley (R-IA) to require prescription drug advertisements to include prices. The move, part of an effort to shine a light on pharmaceutical companies’ high drug prices, provides the US Department of Health and Human Services (HHS) with $1 million to implement rules requiring pharmaceutical companies to list prices of their prescription drugs in direct-to-consu...
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    FDA Recommends Use of Placebo Only in Certain Oncology Trials

    Given the ethical challenges of using a placebo in randomized controlled clinical trials for therapies to treat hematologic malignancy and oncologic disease, the US Food and Drug Administration (FDA) recommends that a sponsor use a placebo-controlled design only in select circumstances, according to new draft guidance released Thursday. Such circumstances include “where surveillance is standard of care,” or with specific trial “design features (e.g. if the trial uses an...
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    Insurers, CVS Call on FDA to Finalize Interchangeable Biosimilar Guidance

    The US Food and Drug Administration (FDA) should finalize guidance on interchangeable biosimilars to increase cost savings, a letter from a group of 17 insurers and other groups, including Kaiser Permanente, Blue Cross Blue Shield and CVS, to FDA Commissioner Scott Gottlieb said on Thursday. By keeping the current interchangeability guidance in draft form , FDA is creating “significant uncertainty” in the biologics market that could discourage similar levels of substit...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 23 August 2018 to include: FDA is adding  Chikungunya virus disease, lassa fev...
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    No-Deal Brexit Scenario: UK Gov Calls to Stockpile Medicines

    UK Health and Social Care Secretary Matt Hancock on Thursday sent letters to the pharmaceutical and medical device industries to warn about what’s to come in what it says is “the unlikely event of a no-deal Brexit.” The letter to pharmaceutical companies calls for an increase in medicine stockpiles by at least six weeks on top of their usual stocks by 29 March 2019 and to ensure plans are in place to air freight products with a short shelf life that cannot be stockpiled...
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    FDA Teams With NASEM on New Opioid Guidelines

    The US Food and Drug Administration (FDA) on Wednesday announced it has awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help advance the development of evidence-based guidelines for appropriate opioid analgesic prescribing for acute pain.  FDA Commissioner Scott Gottlieb said NASEM will conduct a study and issue a report on its findings, beginning with an identification and prioritization of “procedures and conditions assoc...
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    Osteoarthritis: FDA Drafts Guidance on Developing Drugs, Devices, Biologics

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance to help drug, device and biologic sponsors develop products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). The three-page draft features background information on how the agency has relied on patient-reported outcomes in approvals, as well as three bulleted considerations for development. “Approvals for OA to date have been based on patient-repo...
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    Health Canada to Adopt IMDRF Table of Contents Format

    As part of a push toward regulatory convergence, as of 1 April 2019, medical device manufacturers will be expected to submit premarket applications for Class III and Class IV medical devices in Canada in either the International Medical Device Regulators Forum’s (IMDRF) table of contents (ToC) format or Health Canada format. Health Canada announced Tuesday that the Summary Technical Documentation (STED) format will be discontinued as of 1 April 2019, and Health Canada w...
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    FDA Extends Expiration Dates for EpiPens by Four Months

    With a shortage of the life-saving EpiPens persisting, the US Food and Drug Administration (FDA) on Tuesday extended specific lots ' expiration dates by four months. FDA said the extensions are for 0.3 milligram products marketed by Mylan. “We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply,” said Janet Woodcock, director ...