• Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Approves 20th Biosimilar, 5th for Roche’s Herceptin

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s Kanjinti (trastuzumab-anns), which is the fifth biosimilar to be approved for Roche’s Herceptin (trastuzumab) and 20 th biosimilar overall. Although none of the five Herceptin biosimilars have launched in the US yet, the first launches are expected soon. Roche has settled three court cases with Pfizer, Mylan and Biocon, and Celltrion and Teva. Roche also said publicly that it expects competition s...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: MHRA Offers Advice on use of Brand Names to Prescribe Drugs

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   MHRA Offers Advice on use of Brand Names to Prescribe Drugs   The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guideline on the naming of medicinal products. MHRA’s most substantive change is the addition of a new section that provides general recommendations for brand naming and prescribing.   In some cases, products are appro...
  • Regulatory NewsRegulatory News

    UK NB Will Not Apply for EU MDR/IVDR

    London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR). “Following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services,” said LR...
  • Regulatory NewsRegulatory News

    Catalyst Sues FDA Over Approval of Rival Drug

    Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Ruzurgi, which was approved by FDA in May for children with LEMS, will likely compete off-label with Catalyst’s Firdapse (amifampridine), which first won approval in November 2018 but has a list price about twice as...
  • Regulatory NewsRegulatory News

    FDA, USP Clash Over Biologics Monographs

    While the US Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) work closely with one another on many issues, the two are at odds over a proposal that would exclude biological products, including biosimilars, from requirements to adhere to USP monographs.   The proposal, which is included in President Donald Trump’s FY2020 budget request and a discussion draft circulated by the Senate Health, Education, Labor and Pensions (HELP) committee l...
  • Regulatory NewsRegulatory News

    ACell Pays $15M to Resolve Probe Into Failing to Notify FDA of a Market Withdrawal

    The US Department of Justice (DOJ) closed its probe into a devicemaker’s failure to inform the US Food and Drug Administration (FDA) it had withdrawn its powder wound dressing product from the market. ACell pleaded guilty to charges related to its MicroMatrix device and will pay $15 million. The guilty plea charges the Maryland-based devicemaker with one misdemeanor count of failure and refusal to report its 2012 medical device removal, court filings show . A separa...