• EU MDR Q&A: Bos Discusses a Lack of EU-Wide Portfolio Coordination

    With just about 11 months left before the date of the application of the EU’s medical device regulation (MDR), time has not provided the answers to everything. An EU MDR expert spoke to Focus recently via email about four troublesome areas. Gert Bos, executive director and partner at Qserve consultancy, drew attention to issues that have festered in the MDR transition period—a lack of portfolio coordination, an EU-wide supply bottleneck, notified body (NB) capacity an...
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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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    Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline

    This article discusses the value of a Ready-to-use Therapeutic Food (RUTF) and the guidelines for its use. The author explains that because RUTFs are used in the treatment of children with Severe Acute Malnutrition (SAM) without medical complications, a guideline could help ensure products are safe, efficacious and of good quality. She concludes by noting how careful consideration of what should be included in the guideline, as well as provision for consultation with vario...
  • ReconRecon

    Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House allies rally for looming rebate rule ( Politico ) Global Blood’s sickle cell disease drug heads to the FDA, but questions about benefit linger ( STAT ) ( Endpoints ) Facing progressive pressure, Pelosi could expand her drug pricing plan to negotiate prices for $118B worth of drugs ( STAT ) Allscripts is buying ZappRx, a prescription drug start-up (...
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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 and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
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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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    Merck, IBM, KPMG and Walmart Selected for FDA Blockchain Pilot

    The US Food and Drug Administration (FDA) has selected Merck, IBM, KPMG and Walmart to participate in a pilot evaluating blockchain technology to enhance supply chain security, according to a joint press release from the companies.   The pilot is being conducted as part of the FDA’s effort to develop the interoperable track-and-trace system required under the Drug Supply Chain Security Act (DCSCA) by November 2023.   FDA first announced the pilot in February, a...
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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...
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    FDA and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
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    FDA Draft Guidance Seeks to Mitigate Risk of Biotin Interference

    Following a safety communication on an increased risk of adverse events associated with incorrect laboratory test results due to biotin interference, the US Food and Drug Administration (FDA) issued draft guidance on Thursday for testing biotin interference and communicating results with end users. The draft guidance for industry aims to clarify how to test for interference by biotin, also called vitamin B7, on the performance of in vitro diagnostic devices (IVDs) tha...