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    UK Committee Insists on Sanctions for Trial Reporting Failures

    The UK House of Commons Science and Technology Committee echoed on Friday the call from 12 patient groups to impose a system of sanctions for failing to report results of clinical trials.   “The Health Research Authority (HRA) must follow my Committee’s recommendation from last Autumn to introduce a system of sanctions for those who do not comply with reporting results requirements for clinical trials,” Commons Science and Technology Committee Chair Norman Lamb said ...
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    FDA to Roll Out Modernization Plan in Push for Data Interoperability

    An action plan will be rolled out in the coming months to define the US Food and Drug Administration’s (FDA) approach to modernizing its technology infrastructure and framework, FDA Principal Deputy Commissioner Amy Abernethy said during a Thursday keynote at the Office of the National Coordinator for Health Information Technology’s (ONC) 3rd interoperability forum. FDA modernization efforts have been underway in recent years, with the reorganizations of the Center for...
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    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
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    Recon: GSK Anti-BCMA Drug Hits Goal in Multiple Myeloma Study; NICE Rejects GW’s Epidyolex

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Focuses on Novartis Delay in Reporting Data Manipulation ( WSJ ) ( Bloomberg ) ( Endpoints ) Clearside predicts its uveitis drug will be rejected after FDA requests more data ( Endpoints ) FTC Issues Civil Investigative Demand to J&J Regarding Remicade ( Big Molecule Watch ) Report: The Sacklers controlled Purdue like the Godfather controlled the Mafia ( S...
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    Time for FDA to Release Complete Responses Letters? Debate Reignites

    The idea of the US Food and Drug Administration (FDA) releasing complete response letters (CRLs) resurfaced this week as Sarepta Therapeutics received a CRL but refused to make public any portion of it. Following a question on transparency at an event Thursday , Sarepta CEO Doug Ingram said that not releasing the text of the CRL was “a service to the community” and that FDA might not want a confidential letter to be released. “The basis for the CRL is exactly as I've s...
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    Considerations for Development and Implementation of a Companion Diagnostic

    This article discusses four key topics any pharmaceutical company should consider for development and implementation of a Companion Diagnostic (CDx) for use with oncology drugs or biologics.   Introduction   The drug development process in the US is extremely long and costly. It is critical to get the patient a drug that is going to work for them. Especially in the oncology space, drugs for the most part are extremely toxic to the patient. Therefore, not only is th...
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    Final ALS Drug Development Guidance Coming Soon

    Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless on Thursday announced that the agency would finalize guidance on developing treatments for amyotrophic lateral sclerosis (ALS) by the end of September. The 9-page draft guidance, first released in February 2018 , incorporated parts of a draft guidance put together by the ALS Association, known for its viral "ice bucket challenge," which FDA said provided the agency "with scientific advice and insig...
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    CDRH Details Top Regulatory Science Priorities

    In a report released Thursday, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) outlines its top ten regulatory science priorities.   The top ten regulatory science priorities for the center are:   Leverage “big data” for regulatory decision-making Modernize biocompatibility and biological risk evaluation of device materials Leverage real-world evidence and employ evidence synthesis across multiple domains in regulato...
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    Recon: Gilead to Challenge US Patents on Truvada; NICE Chief to Step Down

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to challenge US patents on HIV drug Truvada ( Financial Times ) ( STAT ) ( Bloomberg ) Trump administration appeals drug price disclosure ruling ( The Hill ) ( Reuters ) Retrophin scraps nervous system disorder study, shares dive ( Reuters ) ( Endpoints ) Biotech leaders rally behind Chinese scientists in US, calls for 'measured' policies in wake of pur...
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    Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance

    With a new pilot project, the Danish Medicines Agency (DKMA) is looking to aid device startups and small- to medium-sized manufacturers (SMEs) comply with the EU’s Medical Devices Regulation (MDR). The pilot project will offer guidance on the new regulatory requirements and run from 15 August through the end of 2019, though the regulator will revisit this timeline for a potential continuation. The agency says it “has experienced increasing demand” from medical device...
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    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 22 August 2019 to include: AstraZeneca purchased Sobi's PRV for $95 mill...
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    Edwards Recalls Part of Transcatheter Heart System After One Death

    Last month, Edwards Lifesciences recalled its SAPIEN 3 Ultra Delivery System after reports of burst balloons during implantation, resulting in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, the US Food and Drug Administration (FDA) said Thursday. FDA said 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action early last month. “The use of affected product may caus...