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  • Regulatory NewsRegulatory News

    EMA offers new Q&A on data monitoring committees

    The European Medicines Agency (EMA) on Thursday released a new guideline offering nine questions and answers on issues related to the role of data monitoring committees (DMCs) in the conduct and management of clinical trials.   EMA explains that the recommendations of DMCs are not binding for trial sponsors, but that sponsors should justify and document and instances where such recommendations are not followed.   “The ultimate responsibility for a clinical trial re...
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    Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development

    A bill introduced last year in the US House of Representatives that would reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers could end up costing public and private payers $4.5 billion over 10 years, Harvard Medical School researchers said in an article published Sunday. The economic impact of the bill, which was introduced by Rep. John Shimkus (R-IL), who is not seeking re-election, and co-sponsored by two Democrats, was ...
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    Will Some Biologics Get 30 Years of Exclusivity?

    As the wrangling over the US-Mexico-Canada trade agreement continues, a provision to require Mexico and Canada to accept 10 years of biologic exclusivity stirred up controversy because it would be two more years than what Canada currently enjoys and add five more years for Mexico. In the US, biologic exclusivity is set at 12 years. But in reality, a 30-year run for a biologic without competition is possible, following a court win for Amgen last August. And 15-plus y...
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    FDA Lays Out Tech Modernization Action Plan

    As part of efforts to prepare for the continued rise in data-rich applications and to help fill the gap separating scientific advances and new therapies, the US Food and Drug Administration (FDA) on Wednesday unveiled its Technology Modernization Action Plan (TMAP). Near-term modernization in computer hardware and software technologies are the focus of FDA’s TMAP, which offers a broad overview of how the agency needs to adapt. For instance, the TMAP report notes that FD...
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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...
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    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...
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    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
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    FDA Draft Guidance on Patient Experience Data Incomplete, Critics Argue

    Industry group BIO, the National Association for Rare Disorders (NORD) and the National Center for Health Research (NCHR) called for clarification on how regulators will use draft guidances proposed by external stakeholders on patient experience data. The comments on the US Food and Drug Administration (FDA) draft guidance from December 2018 on developing and submitting proposed draft guidances related to patient experience data showed some consensus around including ...
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    FDA Warns Jubilant, Pfizer Subsidiary in India

    The US Food and Drug Administration (FDA) last week sent warning letters to Pfizer’s subsidiary Hospira and Jubilant Life Sciences over good manufacturing practice (GMP) violations at the companies’ facilities in India.   Pfizer   In its warning letter to Pfizer, FDA says that products made at its Hospira facility in Tamil Nadu, India are adulterated as a result of data integrity breaches and laboratory testing shortcomings observed during a week-long inspection la...
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    EU Taskforce of Pharma Regulators Issues its First Report on Big Data

    A European drug regulators’ taskforce on big data published its first report on Friday. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) formed the HMA-EMA Joint Big Data Taskforce to harness the potential of data in development and oversight, starting with the new report. They examined clinical trial data, spontaneous adverse drug reports (ADRs), social media data and real-world data (RWD) to inform the work and reach “an important mileston...
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    FDA Warns Spanish Firm Over GMP, Data Integrity Issues

    The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.   FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter a...
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    Patient Experience Data: FDA Drafts Guidance

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday published new draft guidance to help stakeholders submit a proposed draft guidance on patient experience data. The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data. “Today’s guidance document is part of our commitment to advance p...