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  • 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...
  • Regulatory NewsRegulatory News
    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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    The US Food and Drug Administration (FDA) on Wednesday issued a new draft guidance consolidating its recommendations on nonclinical safety evaluations for immunotoxicity and withdrew an earlier 2002 guidance on the topic.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...
  • RoundupsRoundups

    Asia Regulatory Roundup: India Commits to Phased Overhaul of Medical Device Regulations

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Commits to Phased Overhaul of Medical Device Regulations   The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law that will increase oversight of all medical devices on 1 April but will defer enforcing the new requirements for upward of 18 months.   Last year, the Indian ...
  • Regulatory NewsRegulatory News

    FDA Touts Generic Drug Research in 2019

    The US Food and Drug Administration (FDA) on Tuesday released a report detailing the scientific research carried out and funded by the agency in FY2019 to support the development of generic drugs under the Generic Drug User Fee Amendments (GDUFA II).   The 83-page report provides an overview of the research activities related to 13 research areas that fit within the four scientific priorities FDA set for FY2019, which include: complex active ingredients, formulatio...
  • Regulatory NewsRegulatory News

    ICH E9(R1) and S5(R3) to Take Effect in EU by End of July

    More than two years after opening public consultations on the guidelines, the European Medicines Agency (EMA) on Tuesday adopted two International Council for Harmonisation (ICH) guidelines, the ICH E9(R1) addendum on estimands and sensitivity analysis in clinical trials and ICH S5(R3) on reproductive toxicology, with both guidelines set to take effect on 30 July 2020.   EMA’s move to adopt the guidelines comes after ICH adopted the E9(R1) addendum at its November meet...
  • Regulatory NewsRegulatory News

    UK Steps Back From ‘Leading Authority’ for Drugs in Brexit Transition

    The UK will not act as a “leading authority” for medicines during the one-year Brexit transition, although UK and EU negotiators are still trying to fine-tune what that means in practice, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said in an updated guidance on Tuesday. The meaning of “leading authority” depends on interpreting Article 123 of the draft withdrawal agreement, which says : “During the transition period, the United Kingdom shall no...
  • Regulatory NewsRegulatory News

    Updated: Striking While the Iron is Hot: FDA Corrects New NDA, BLA Filings in Q1 of FY 2020

    As the US Food and Drug Administration (FDA) continues to approve more new drugs more quickly, the number of new application filings in the first quarter of FY 2020 (through 31 December 2019) seemed at first to have increased dramatically when compared to FY 2019 and 2018. FDA initially said this latest quarter saw 74 new drug application (NDA) filings and 32 biologics license application (BLA) filings, which compared with a total of only 26 BLA filings in all four quar...
  • Feature ArticlesFeature Articles

    Demonstrating Regulatory Value

    This article discusses the critical role of regulatory and highlights the value regulatory professionals bring to an organization in terms of their contribution to cost savings and eventual product earnings.   Introduction   In the current economic environment, biopharmaceutical sponsors are being asked to achieve more with less resources. The critical role of regulatory needs to be highlighted in terms of their contribution to cost savings and eventual product ear...
  • ReconRecon

    Recon: Sanofi/BARDA Team Up on Coronavirus Vaccine; NHS Starts Luxturna Gene Therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi announces it will work with HHS to develop coronavirus vaccine ( STAT ) ( Reuters ) ( Press ) The top 100 biopharma venture investors at the megabillions deal table ( Endpoints ) ‘Pharma doesn’t like fish oil’: Wall Street funds sold Amarin after big win with heart drug ( STAT ) FDA goes on high alert as coronavirus raises threat to drug manufacturing a...