• Regulatory NewsRegulatory News

    Former FDA Commissioners Make the Case for an Independent Regulatory Agency

    At a plenary session at the American University in Washington, DC four former US Food and Drug Administration (FDA) commissioners argued for FDA to become an independent regulatory agency. The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute on Friday featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach. Lewis Grossman, professor of law at...
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    FDA Tweaks List of Recognized Consensus Standards for Devices

    A total of about 90 consensus standards used for device premarket reviews and other device regulatory requirements will undergo certain modifications set forth Friday in a notice from the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).   The 14-page notice “will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices,” CDRH said. It includes a list of the modif...
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    Health Canada Puts Brakes on SaMD Draft Guidance

    A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document. The advisory panel, which included the US Food and Drug Administration (FDA), Canada’s medical technology companies (MEDEC), the Council of Canadian Innovators (CCI) and the National Research Council, among others, deliberated on questions Health Canada provided regarding its draft guidance on SaMD ...
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    EMA’s CHMP Recommends Six Medicines for Approval

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced the recommendation of six medicines for approval, including two orphan medicines, as well as three extensions of indications and a new vice-chair.   Of the six medicines, at its October meeting, CHMP recommended granting an authorization for Shire’s Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of heredi...
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    European Commission Offers Guidance on UDIs

    Building off guidance released in March, the European Commission this month unveiled five new guidance documents on the use of unique device identifiers (UDIs).   The guidances deal with UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding l...
  • ReconRecon

    Recon: Vertex Touts Positive Preliminary Results for Three Drug CF Combo; AbbVie CFO to Retire

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump’s Drug Price Bust ( WSJ ) Orphan Drugs in the United States ( IQVIA ) ( PharmaLetter -$) Abbvie CFO Chase to Retire Next Year ( Reuters ) ( Fierce ) Vertex Three-drug combination improves life for cystic fibrosis patients ( NBC ) ( Press ) ( NEJM ) Proteostasis shares zoom north as their cystic fibrosis doublet causes a stir in small study — triggering ...
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    EU Regulatory Roundup: MHRA Starts Sharing Intel With India to Curb Imports of Unlicensed Drugs

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Reports Double-Digit Decline in Use of Veterinary Antimicrobial Agents   The European Medicines Agency (EMA) has reported a double-digit decline in sales of veterinary antimicrobial agents across 30 countries in the region. Overall, use of the products in food-producing animals fell by more than 20% between 2011 and 2016.   The downward trend was driven by s...
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    CDRH Issues Final Orders on 6 Medical Device Classifications

    A set of final orders issued by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) on Thursday established new classifications for six device types.   The final orders cover devices indicated for use in surgery, ophthalmology, anesthesiology and neurology, and classify five new device types into class II (special controls) and one into class I. The classifications were developed based on the de novo classification requests CDRH rece...
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    Manufacturers Not Ready for November DSCSA Deadline, Study Finds

    A new study found that pharmaceutical manufacturers are woefully behind in meeting a 27 November deadline, as nearly 80% of pharmaceutical packages still do not have a readable barcode with all four required data elements necessary to meet the requirements of the Drug Supply Chain Security Act (DSCSA).   The study, from AmerisourceBergen, Cardinal Health and McKesson Pharmaceutical, which represent about 90% of pharmaceutical distribution in the US, examined package ...
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    EMA Announces Pharmacovigilance Fee Increase

    Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.   Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.   The increased fee rate was established under Commissioner Delegated Regulation (EU)...
  • ReconRecon

    Recon: Novartis to Buy Endocyte for $2.1B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Proposed Rule Requiring Drug Prices in TV Ads Could Impact Marketing Strategies ( WSJ ) Requiring Price Info in Drug Ads May Strain Agency Authority ( Bloomberg ) The Trump administration hints at new drug pricing regulations on Medicaid, biologics ( STAT ) FDA slaps down Novartis’ blockbuster pitch for canakinumab — so what went wrong? ( Endpoints ) FDA slap...
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    FDA Looks to Harmonize Generic Drug Scientific and Technical Standards via ICH

    The US Food and Drug Administration (FDA) revealed Thursday that it’s offering a proposal to the International Council on Harmonisation (ICH) to better harmonize scientific and technical standards for generic drugs. The plan is to allow generic drug developers to implement a single global drug development program, with common elements of applications to file, to allow for simultaneous approvals in multiple markets. “This would make it easier for developers that would...