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    Regulatory NewsRegulatory News

    Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway France Fines J&J Over Painkiller Patch (20 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Best of 2017: What Readers Clicked on This Year ( Focus ) GOP Finally Notches 2017 Victory While Bracing for 2018 Verdict ( NYTimes 1, 2 ) ( Washington Post ) ( Senate Finance ) House to vote again on tax bill; Trump on verge of win ( Reuters ) FDA Medical Device Proposal May Skirt the Law: Legal Experts ( Reuters ) NY AG Announces $13.5M Multi-State Settleme...
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    Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act. Un...
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    Regulatory Recon: FDA Approves Aerie's Glaucoma Drug US Lifts Funding Ban on High Risk Virus Research (19 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Aerie's glaucoma treatment gets early FDA approval ( Reuters ) ( Endpoints ) ( Press ) Dr. Reddy's resolves US probe over child safety of drug packaging ( Reuters ) ( Economic Times ) US lifts moratorium on funding controversial, high-risk virus research ( STAT ) Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill ( Focus ) FDA Plots New...
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    Use of Standards at CBER: New Draft Guidance

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions. Questions and answers contained within the draf...
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    Regulatory Recon: Whistleblowers Say DEA Went Easy on McKesson Ultragenyx Sells PRV to Novartis for $130M (18 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The Winners and Losers in the Tax Bill ( NYTimes ) Whistleblowers: DEA attorneys went easy on McKesson, the country's largest drug distributor( 60 Minutes ) ( Washington Post ) ( STAT ) Ultragenyx Sells Priority Review Voucher to Novartis for $130 million ( Press ) ( Endpoints ) In Opioid Battle, Cherokee Want Their Day in Tribal Court ( NYTimes ) CRISPR in ...
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    Regulatory Recon: FDA Lifts Hold on Alnylam Hemophilia Trials EMA Recommends 7 New Medicines for EU Approval (15 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Aclaris's drug to treat common skin growth gets FDA nod ( Reuters ) FDA allows Alnylam to restart hemophilia treatment trials ( Reuters ) ( Endpoints ) ( Press ) Pfizer's Xeljanz gets FDA nod as joint disease treatment ( Reuters ) ( Press ) To Be (a Device) Or Not to Be? That Is the Question ( Fortune ) CAR T cells — what have we learnt? ( Nature ) What's Com...
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    European Regulatory Roundup: Critical Moment for EMA (15 December 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Commission Creates Roadmap for Evaluation of Pediatric Rare Disease Legislation The European Commission has created a roadmap for evaluating legislation covering pediatric rare diseases. Officials are embarking on the nearly two-year evaluation to understand why regulations on pediatric and orphan medicines have failed to translate into the hoped-for medical advances. ...
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    What's Coming in 2018: FDA's Regulatory Agenda

    The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs. On the compounding front, FDA plans to issue a proposed rule in August 2018 that would set minimum current good manufacturing practice requirements for human drug products compounded by an outso...
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    Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients Teva to Cut 14,000 Jobs (14 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Months After Approval, Breakthrough Cancer Drug Given to Just Five Patients ( Bloomberg ) Pfizer's second biosimilar of J&J's Remicade wins FDA approval ( Reuters ) ( Pharmafile ) ( Press ) FDA Panel Gives Thumbs Down to Spine Device ( Medpage ) ( EP Vantage ) Drug Companies' Liability for the Opioid Epidemic ( NEJM ) Pharma industry's return on R&D investment...
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    Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Why a drug for aging would challenge Washington ( Politico ) FDA statement on The Uncertain Hour's OxyContin episode ( Marketplace ) How Alex Azar could try to shake up drug prices through Medicare Part B ( STAT ) Some drug makers are considered good corporate citizens ( STAT               ) What pharma's watching as Congress tries to hammer out a tax bill ( S...
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    Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Australia, Singapore Expand Generic Drug Work-Sharing Trial A regulatory consortium featuring Australia and Singapore has expanded its generic medicine work-sharing program. The initiative allows companies to file for approval with multiple agencies, which then perform a coordinated assessment of the application before reaching individual decisions. Agencies in Aust...
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    Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis Allergan Acquires Ailing Repros (12 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA warns companies for promoting alternatives to street drugs ( FDA ) FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis ( FDA ) Allergan buys an ailing Repros, bagging a women's health drug for the pipeline ( Endpoints ) FDA Plans New Medical-Device Approval Processes ( WSJ ) ( Reuters ) ( FDAVoice ) Three more drug makers allegedly us...