• Regulatory NewsRegulatory News

    FDA Awards $4M in Grants to Support Development of COAs

    As part of the US Food and Drug Administration’s (FDA) work to develop publicly available Clinical Outcome Assessments (COAs), the agency awarded three grants to researchers at Albert Einstein College of Medicine, Duke University and Northwestern University. The grants, which total about $4 million, are meant to help collect patient input to inform the selection of clinical outcomes and how data is collected. “If methodologically sound data collection tools are devel...
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    FDA Explains Plans for New Pharmaceutical Quality Assessment System

    As part of its work to improve and modernize the quality assessment of drug applications, the US Food and Drug Administration (FDA) is developing a new, more standardized system, to be known as the Knowledge-aided Assessment & Structured Application (KASA), according to an article authored by officials from FDA’s Center for Drug Evaluation and Research and published in the latest issue of the International Journal of Pharmaceutics . The authors describe KASA as a new s...
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    FDA Issues 53 Product-Specific Guidances to Help With Generic Drug Development

    The US Food and Drug Administration (FDA) on Monday released 53 product-specific guidance documents to aid generic drug development, including 34 new guidance documents, 26 guidances for treatments that lack generic competition and 16 for complex products. When finalized, the guidance documents will represent the current thinking of FDA on, among other things, the product-specific design of bioequivalence studies to support abbreviated new drug applications. Among th...
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    Recon: Lundbeck Buys Alder for $2B; Purdue Pharma Files for Bankruptcy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First peanut allergy treatment gains backing from FDA advisory panel ( Science ) ( Atlantic ) ( AP ) Purdue Pharma, maker of OxyContin and other drugs, files for bankruptcy ( Stat ) ( Bloomberg ) ( WSJ ) ( Guardian ) Opioid Defendants Seek to Disqualify Judge Overseeing 2,300 Cases ( NY Times ) The Startup That Manipulated Data to Get a Miracle Drug to Market ...
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    Three Breast Cancer Drugs: FDA Warns of Rare but Serious Lung Inflammation

    The US Food and Drug Administration (FDA) on Friday warned that breast cancer drugs, Ibrance (palbociclib) from Pfizer, Novartis' Kisqali (ribociclib) and Lilly's Verzenio (abemaciclib) may cause rare but severe inflammation of the lungs that could lead to death. “We have approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire class of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The overall bene...
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    FDA Tells Company to Pull Press Release on Drinking With Female Libido Drug

    Last April, Sprout Pharmaceuticals completed postmarketing trials for its drug Addyi (flibanserin), which is used to treat decreased sexual desire in women, and the US Food and Drug Administration (FDA) said it could change the labeling of the drug to clarify that although a boxed warning is still necessary, alcohol does not have to be avoided completely. FDA’s decision on the label followed a push from Sprout to remove the warning entirely. Sprout touted newly released...
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    EMA, FDA Begin Reviewing Heartburn Medicines for Carcinogen

    Following its investigation into an impurity called N-nitrosodimethylamine (NDMA) in blood pressure medicines, the European Medicines Agency (EMA) on Friday said that, at the request of the European Commission, it’s beginning a review of ranitidine medicines after tests showed that some contained the impurity. NDMA is classified as a substance that could cause cancer on the basis of animal studies, although EMA explains how it is present in some foods and in water suppl...
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    UK Warns Again: No-Deal Brexit Could Disrupt Medicine Supplies

    The UK government on Wednesday published a previously sensitive document explaining how a no-deal Brexit beginning on 31 October could strain trade across the English Channel for up to six months. “The reliance of medicines and medical products’ supply chains on the short straits crossing make them particularly vulnerable to severe extended delays; three-quarters of medicines come via the short straits,” the document, first drafted in August and dubbed “Operation Yellow...
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    510(k) Submissions: CDRH Releases Four Final Guidances

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday released four final guidance documents on the Special 510(k) program, the abbreviated 510(k) program, how to format traditional and abbreviated 510(k)s and CDRH’s refuse to accept policy for 510(k)s. As part of a wider, ongoing push to modernize FDA’s 510(k) program, the final guidance documents provide more clarity on several programs the agency has been working on...
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    EU Regulatory Roundup: ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   ENVI Pushes for EU to Give EMA More Money, Staff to Cover Extra Work   The European Parliament’s health committee has renewed its call for the region’s drug regulator to be given more money and staff. ENVI, the Committee on the Environment, Public Health and Food Safety, made the comment in its opinion about the European Union’s 2020 budget proposal.   Pascal Ca...
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    Study Finds Extent of Unvalidated Surrogate Endpoint Use in Expedited Approvals ‘Concerning’

    Research published this week in PLOS Medicine raises concerns about the use of surrogate endpoints to support the marketing authorizations of products assessed via the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA) and accelerated assessment (AA) pathways. The use of the CMA and AA pathways, which is restricted to situations of “unmet medical need” and/or “in the interests of public health,” are often based on incomplete benefit-risk asses...
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    EC Explains New MDR, IVDR Rules for Designating Expert Device Panels

    The European Commission (EC) on Wednesday published an implementing decision on how new medical device expert panels will be designated under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The panels will provide scientific, technical and clinical assistance to the EC, the Medical Device Coordination Group (MDCG), member states, notified bodies and device manufacturers. In particular, the implementing decision notes that notified bodies ...