• Regulatory NewsRegulatory News

    EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

    European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio. Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implement...
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    GAO Reports on FDA, Drugmaker Efforts to Boost Access to Investigational Drugs

    A new report from the Government Accountability Office (GAO) finds that drugmakers and other stakeholders are largely supportive of steps taken by the US Food and Drug Administration (FDA) to facilitate access to investigational drugs, both through clinical trials and via expanded access or right-to-try requests.   Specifically, the report looked at actions FDA has taken to broaden clinical trial eligibility, improve access to investigational drugs outside of clinical ...
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    CDRH Committee Discusses Challenges in Communicating Cybersecurity Concerns

    The US Food and Drug and Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday convened its Patient Engagement Advisory Committee (PEAC) to discuss the difficulties and challenges in communicating cybersecurity safety risks and threats. Since 2013, CDRH has released safety communication related to eight device cybersecurity concerns, although the center notes that issues are customarily disclosed when there is a software update to fix an is...
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    FDA Warns Drug Manufacturers as FTC Warns CBD Advertisers

    The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to South Korea-based drug manufacturer Enprani Co. and China-based drug manufacturer Hangzhou Badi Daily Use Chemical Company. Meanwhile, the Federal Trade Commission (FTC) on Tuesday said it sent warning letters to three unnamed companies for illegal advertising of products containing cannabidiol (CBD). The letter for Enprani, which follows a five-day inspection last March, shows how...
  • ReconRecon

    Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinckrodt to Sell BioVectra for $250M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi’s drug pricing plan is more aggressive than expected ( STAT ) ( NYTimes ) ( Washington Post ) ( CNBC ) ( The Hill ) US judge allows public nuisance claim in opioid trial ( Reuters ) Sackler Family To Give Up Value Of Purdue Pharma To Settle Opioid Claims ( NPR ) Delaware DOJ files lawsuit against Sackler family, owners of Purdue Pharma companies ( Delaw...
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    US Government Wants to Know More About the Biotech Ecosystem

    The White House’s Office of Science Technology and Policy (OSTP) on Tuesday sought input from any and all biotech stakeholders on the innovation, products, technology and data derived from biologically-related processes and science that drive economic growth, promote health and increase public benefit. Referred to as the “Bioeconomy,” OSTP said it’s seeking comments before 23 October from the public, including those with capital investments, those performing research or...
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    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
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    Drugmakers Seek Clarity on Two FDA Labeling Guidances

    Drugmakers and industry groups are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on product labeling, one covering instructions for use (IFU) for drugs, biologics and combination products and the other providing recommendations on drug abuse and dependence labeling.   IFU Patient Labeling   In its comments, the Combination Products Coalition (CPC) said it appreciates the aim of the guidance, but requested the agency clari...
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    FDA Investigates Thousands of Adverse Events Linked to Compounded Hormone Drugs

    The US Food and Drug Administration (FDA) said Monday that an inspection of an outsourcing facility uncovered information about 4,202 adverse events linked to compounded hormone pellets that had never been reported to the agency. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement that the mishap highlights the need for compounders of drugs and other affiliated organizations to report adverse events promptly.   “The adver...
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    FDA Developing Guidance on Real-World Data Quality Issues, Officials Say

    As the US Food and Drug Administration (FDA) grapples with how to use real-world data for regulatory decisions, two FDA officials wrote in a perspective published last Friday in the Clinical Journal of the American Society of Nephrology that the agency is developing guidance on data quality issues unique to the real-world data setting and related study design considerations. Aliza Thompson and Mary Ross Southworth of the Division of Cardiovascular and Renal Products w...
  • ReconRecon

    Recon: Amgen, Lilly Report Tumor Shrinkage in KRAS, RET Lung Cancer Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lung cancer drug Lilly bought for $8 billion delivers strong results ( STAT ) ( Endpoints ) ( Reuters ) Amgen Slips as Gene-Targeting Drug Misses Some ‘Lofty Hopes’ ( Bloomberg ) ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Sacklers Reject Demand That They Surrender Personal Wealth To Settle Opioid Claims ( NPR ) Novartis Makes New Data Integrity Commitment ( ...
  • Regulatory NewsRegulatory News

    Novartis Makes New Data Integrity Commitment

    Looking to slow the fallout from Novartis’ data manipulation fiasco with its billion-dollar gene therapy Zolgensma (onasemnogene abeparvovec-xioi), CEO Vasant Narasimhan told an investor conference on Monday that the company will be more proactive in reporting data integrity issues to the US Food and Drug Administration (FDA). “We are voluntarily and proactively taking a pledge with the FDA to ensure that we will inform them within five business days of any credible all...