• Regulatory NewsRegulatory News

    FDA Finalizes Rule to Go From Paper to Electronic Device Submissions

    As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission. The agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order ...
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    Drug Development Tools: FDA Drafts Guidance on Qualification Process

    The US Food and Drug Administration (FDA) on Friday issued draft guidance explaining its qualification process for drug development tools (DDTs) in line with the 21 st Century Cures Act.   The 20-page draft guidance comes just ahead of the deadline set in the Cures Act and fulfills some of FDA’s Prescription Drug User Fee Act (PDUFA VI) commitments to enhance its DDT qualification pathway for biomarkers.   Section 507 of the Federal Food, Drug, and Cosmetic...
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    Questions Linger With Swiss-EU MRA and Device Regulation

    The medical device association in Switzerland and two attorneys at Sidley Austin are raising questions about the mutual recognition agreement (MRA) between the EU and Switzerland and its impact on the trade of medical devices. Following the changes coming with the EU’s Medical Devices Regulation (MDR), Switzerland is revising its own regulations. On 26 May 2020, MDR will take effect and according to the regulator Swissmedic , the EU regulation is currently being tra...
  • ReconRecon

    Recon: Sarepta Wins Early Approval for DMD Drug After Earlier Rejection; PhRMA Sues Over Oregon Price Transparency Laws

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA gives early approval to Sarepta's DMD therapy  ( Reuters ) ( STAT ) ( Endpoints ) ( Endpoints ) ( FDA ) What's next for Sarepta? A third DMD approval, analysts predict ( Endpoints ) Biotech veteran Chris Garabedian on Sarepta’s legacy and Biogen’s future at the FDA ( STAT ) Biogen scraps development of therapy for rare brain disease ( Reuters ) Hahn Wins ...
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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 13 December 2019 to include: Sarepta Pharmaceuticals received a PRV for ...
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    Hahn Wins Senate Confirmation to be 24th FDA Commissioner

    The full Senate voted on Thursday 72-18 to confirm Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next commissioner of the US Food and Drug Administration (FDA). The vote came just over a month since he was nominated, although in that time little information has come to light about how he plans to direct FDA, which oversees products that account for about 20 cents of every dollar spent by US consumers. Still, senators on bot...
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    House Passes Pelosi Drug Pricing Bill on Party-Line Vote

    House Democrats on Thursday fell in line behind Speaker Nancy Pelosi’s (D-CA) drug pricing bill, voting for its passage 230-192, with two Republicans voting for it -- Reps. Brian Fitzpatrick (PA) and Jaime Herrera Beutler (WA). The bill is not likely to be taken up in the Senate, and was derided by House Republicans as being too partisan and putting the development of many new treatments at risk. President Donald Trump, who praised the Pelosi effort when it was first ...
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    Recon: FDA Authorizes First Newborn DMD Screening Test; Amgen, UCB Osteoporosis Drug Evenity Wins EU Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Big Pharma Will Target Smaller Deals in 2020, JPMorgan Predicts ( Bloomberg ) New drugs show rare promise against advanced breast cancer ( AP ) CVS to increase genetic testing for some Aetna cancer patients ( Reuters ) Gilead's Kite files for FDA approval of second CAR-T therapy ( Fierce ) ( Endpoints ) ( Press ) Express Scripts throws a lifeline to digital h...
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    When FDA Requires Pediatric Studies for New Cancer Drug Submissions: New Draft Guidance

    Beginning 18 August 2020, biopharma companies will begin submitting pediatric assessments of certain molecularly targeted oncology drugs for which new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to the US Food and Drug Administration (FDA). New FDA draft guidance published on Thursday explains how sponsors will need provide such submissions and what factors will be considered. “Specifically, if an original NDA or BL...
  • RoundupsRoundups

    EU Regulatory Roundup: Finland Prepares for 2020 Introduction of New Clinical Trial Regulations

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   EMA Seeks Feedback on Tracking Drug Safety in Pregnancy and Breastfeeding   The European Medicines Agency (EMA) is seeking feedback on its draft good pharmacovigilance practice (GVP) guideline. The draft covers specific considerations for dealing with adverse events in pregnant and breastfeeding women.   EMA wrote the GVP guideline in light of the fact pregnant ...
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    MDCG Offers New Guidance on MDR, IVDR Sampling, Codes

    The Medical Device Coordination Group (MDCG) on Wednesday released two new guidance documents: One document to define the requirements of sampling Class IIa and Class IIb devices under the Medical Devices Regulation (MDR) and Class B and Class C devices under the In Vitro Diagnostic Regulation (IVDR), and one document on the different MDR codes. The first 8-page guidance defines and further elaborates on the sampling criteria and use of such criteria for drawing up and ...
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    EMA: Signal Management Improved After Pharmacovigilance Reforms

    The European Medicines Agency (EMA) on Wednesday touted the results of a six-year review that show improvements to signal management for medicines within the EU following pharmacovigilance reforms in 2012.   In 2010 and 2012, the EU introduced new directives and regulations amending its pharmacovigilance requirements, which came into force under the new pharmacovigilance legislation .   “In the first six years since the implementation of the 2012 EU pharmacovigila...