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    FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids. The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration ...
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    Drugmakers Seek Tweaks to FDA Guidance on Bispecific Antibodies

    The US Food and Drug Administration (FDA) should clarify certain aspects and revise certain sections of a draft guidance on developing bispecific antibodies, AstraZeneca, Regeneron, Novartis, Janssen, Pfizer and Eli Lilly said in comments submitted to the agency this week. The draft guidance, released in April , discusses the promise behind bispecific antibodies and the development challenges. Examples of bispecific antibodies marketed in the US include Amgen’s Blin...
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    Woodcock Offers 180-Day Exclusivity Tweaks as Senate Committee Preps for Vote

    The Senate health committee said it plans to vote on a wide-ranging bill with implications for the US Food and Drug Administration (FDA) next Wednesday and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, laid out FDA’s views on several proposals at a Senate Aging Committee hearing on Wednesday. The bipartisan bill from the committee mirrors a discussion draft released in May and includes a new section that would give FDA new authorities to...
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    Another Notified Body Bows Out Ahead of EU MDR: 'Investment Too High’

    Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain. Ursula Roesler, head of medical devices at QS Zürich AG, told Focus that the medical device department will be closed by the end of October. As far as why the decision was made, Roesler said, “It was a business decision of the CEO—the investment was too high for a small NB like QS Zürich AG....
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    FDA Releases New Data to Help Generic Drug Competitors

    Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday. Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that ...
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    EMA Begins Review of Handling Errors Linked to Leuprorelin

    At the request of Germany’s BfArM, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of depot formulations of leuprorelin medicines because of reports of handling errors during preparation and administration that can cause some to receive insufficient amounts. EMA explains how depot formulations of leuprorelin medicines, which are better known by different brand names like Eligard, Lupron and Procren, release the...
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    EMA to Reinstate Some Activities Halted by Brexit

    While noting some progress in its Brexit preparations on transferring medicine marketing authorizations from the UK to the EU, the European Medicines Agency (EMA) on Monday announced a series of activities that will ramp up, in addition to the highest priority activities, for the remainder of 2019. But EMA also reiterated that between 20% and 25% of the agency’s staffers are expected to leave. And in the most recent EMA update, of the agency’s 776 staff members, 464 hav...
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    Drugmakers Sue HHS for Trying to Add Prices to DTC Ads

    Amgen, Merck, Eli Lilly and the Association of National Advertisers on Friday sued the Department of Health and Human Services (HHS) because of a rulemaking that would require pharmaceutical list prices to be shown in direct-to-consumer (DTC) drug advertisements on television. The rule, which was finalized in May and is set to take effect in July, requires that television advertisements for prescription drugs or biological products with a list price of $35 or more con...
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    ICH Adds Four New Regulatory Observers

    Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam. ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revisi...
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    May 2020 MDR Deadline is ‘Realistic and Achievable,’ EU Health Commissioner Says

    While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.” Vytenis Andriukaitis’s comments at a meeting of EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) in Luxemburg followed concerns raised this week by German and Irish delega...
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    FDA Warns of One Death Linked to Fecal Transplants

    The US Food and Drug Administration (FDA) on Thursday warned medical and scientific communities and other interested persons of the potential risk of transmitting multi-drug resistant organisms (MDROs) via poop transplants, otherwise known as fecal microbiota for transplantation (FMT). FMT is typically used to help patients with the bacterium  Clostridium difficile who are not responding to standard therapies. 2013 guidance from FDA revealed that the agency intends t...
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    Senators Seek Details on Sharing US Genomic Data With Companies Linked to China’s Government

    Sens. Chuck Grassley (R-IA) and Marco Rubio (R-FL) sent a letter earlier this week to the Acting Inspector General of the US Department of Health and Human Services raising concerns about the US Centers for Medicare and Medicaid Services (CMS) paying for genetic testing or analysis services from companies with ties to the Chinese government. The letter singles out WuXi Nextcode Genomics (WuXi) and Shenzhen BGI Technology Company (BGI) as publicly touting their partnersh...