• Regulatory NewsRegulatory News

    Drug Approvals: FDA Publishes Dataset of CDER Approvals Since 1985

    To provide researchers with more accurate and accessible data about historic drug approvals, the US Food and Drug Administration (FDA) on Friday released a dataset containing information about all new drugs and biologics approved by the Center for Drug Evaluation and Research (CDER) dating back to 1985.   “FDA created the compilation to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug,” FDA writes, addin...
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    FDA Finalizes eCTD Guidance, Consults on eCTD v4.0 Technical Documents

    The US Food and Drug Administration (FDA) on Friday finalized the seventh revision to its guidance on making regulatory submissions in electronic common technical document (eCTD) format to specify cases where an exemption or waiver from eCTD requirements is warranted.   The 17-page guidance finalizes a draft version released in July 2019 and replaces the previous final version from January 2019.   Within the guidance, FDA says it will exempt all Type III drug m...
  • ReconRecon

    Recon: Canada Weighs Changes to Drug Pricing Rules; No AdComm for Biomarin’s Valrox

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review ( Fierce ) ( Endpoints ) ( Press ) Stalled Initiatives to Cut Drug Prices Frustrate Trump ( WSJ ) Gilead loses another challenge to a pair of US patents for an HIV prevention pill ( STAT ) ( Endpoints ) Bankrupt antibiotics maker Aradigm turns to old partner/investor for final $3M fire sal...
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    Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

    The US Food and Drug Administration (FDA) on Thursday published a table identifying more than 50 gene-drug interactions that the agency says are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations.   “Consistent with our mission to protect and promote public health, we believe it is important to take steps now to help ensure that claims being made for pharmacogenetic tests offered today are grounded...
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    FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

    A month before the long-anticipated transition of applications for certain biological products, including insulin and human growth hormone, to be deemed to be licensed as biologics, the US Food and Drug Administration (FDA) on Thursday issued a final rule amending its definition of “biological product.”   The final rule is one of the last steps in the decade-long transition set in motion by the Biologics Price Competition and Innovation Act of 2009 (BPCIA) to deem ap...
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    EU Regulatory Roundup: Accord, Glaxo Issue FMD Alerts Over 2D Barcode Problems

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   Accord, Glaxo Issue Falsified Medicines Directive Alerts Over 2D Code Problems   Accord Healthcare and Glaxo Wellcome have shared alerts about issues related to compliance with the Falsified Medicines Directive. The alerts are tied to the information encoded on serialised 2D codes.   Glaxo’s situation, which the drugmaker reported to the United Kingdom’s Medicines...
  • ReconRecon

    Recon: GSK, Immatics Partner on Immunotherapies; Teva’s Austedo Fails in Two Tourette’s Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA deems Abbott Vascular, ResMed, Teleflex recalls high risk ( MedtechDive ) Fisher Wallace files citizen petition over FDA’s class III designation for CES ( BioWorld ) AI discovers antibiotics to treat drug-resistant diseases ( Financial Times ) ( STAT ) Lawmakers to Trump: Don’t give ‘monopolies’ to companies that develop coronavirus treatments with taxpaye...
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    RAPS' LatestRAPS' Latest

    EU MDR: Learning as We Go

    With full application of the EU Medical Device Regulation (EU MDR) just around the corner on 26 May 2020, it’s fair to say many device manufacturers and regulatory professionals are on edge. And although we are coming to the end of the three-year transition period, it’s sometimes seemed like we have been struggling to play catch up from very start of the process.   Some of that is in the nature and scale of EU MDR as compared to the Medical Device Directive that has be...
  • Feature ArticlesFeature Articles

    Communicating the Importance of Regulatory to Various Stakeholders

    This article focuses on the importance of a strong regulatory compliant culture within an organization and proclaims that without the support and involvement of various stakeholders, it is impossible to reach and maintain this culture. The author explains how regulatory professionals can effectively communicate the importance of regulatory to help the organization meet its goals.   Introduction   “How much will it cost?” is one of the first questions asked by compa...
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    Health Canada Begins Implementing eCTD for Clinical Trial Applications

    Following a successful pilot that wrapped up in August, Health Canada says it will immediately begin accepting certain clinical trial submissions in electronic common technical document (eCTD) format.   In recent years, Health Canada has moved to increasingly accept or require eCTD format for various submissions, including new drug submissions (NDS), abbreviated new drug submissions (ANDS) and drug master files (DMFs).   Specifically, Health Canada says it will all...
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    FDA Consolidates Nonclinical Immunotoxicity Evaluation Guidance

    The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.   FDA says the guidance addresses issues related to evaluating immunotoxicity including immune suppression, modulation and stimulation and provides recommendations for carcinogenicity assessments, dermal sensitization, adjuvanted vaccine development a...
  • ReconRecon

    Recon: Roche Nabs Priority Review for Tecentriq in NSCLC; FDA Rejects 6-Week Dosing Schedule for Keytruda

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump's next health care move: Giving Silicon Valley your medical data ( Politico ) How the Drug Lobby Lost Its Mojo in Washington ( WSJ ) FDA sets June decision date for Tecentriq monotherapy in NSCLC ( PMLive ) ( Press ) FDA rejects Merck’s applications for 6-week Keytruda dosing schedule ( Reuters ) ( Press ) BMS’ Opdivo combo misses the mark in pancreatic...