FDA Sets Public Hearing on Predictive Toxicology Roadmap

The agency's Toxicology Working Group recommended a six-part roadmap for achieving FDA's goals of ensuring the agency continues to use cutting-edge science to assess the safety and effectiveness of its regulated products and also leverages advances made in toxicology.

The U.S. Food & Drug Administration will hold a public hearing Sept. 12 to get public comments on its Predictive Toxicology Roadmap. At the hearing, scheduled to last from 9 a.m. to 4 p.m., the agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review. Anyone interested in attending the hearing must register by Aug. 29.

Released in December 2017, the roadmap is a 16-page document developed by FDA's Toxicology Working Group at the request of FDA's commissioner. The working group recommended a six-part roadmap for achieving FDA's goals of ensuring the agency continues to use cutting-edge science to assess the safety and effectiveness of its regulated products and also leverages advances made in toxicology.

The six parts are:

  • Organizing committee -- the Toxicology Working Group.
  • Training -- Saying continuing education in new predictive methods is essential for FDA regulators, the working group has established an agency-wide education calendar of events and a toxicology seminar series to provide this.
  • Continued communication with stakeholders.
  • Collaborations across sectors and disciplines both nationally and internationally.
  • Research to identify gaps and support intramural and extramural research to ensure the most promising technologies are identified, developed, validated, and integrated into the product pipeline.
  • Oversight -- The working group will track progress on these recommendations and report to FDA's chief scientist annually.

In its online page inviting public participation, FDA said it expects "breakthrough methods" will help it move products to market faster and prevent products with increased toxicological risk from reaching the market, and these new technologies are reducing the need for animal testing – furthering FDA's goal of refining, reducing, and replacing testing on animals.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • The Top 5 Safety and Technology Trends to Watch in 2019

    Get the latest on trends you can expect to hear more about in 2019, including continued growth of mobile safety applications, wearable technology, and smart PPE; autonomous vehicles; pending OSHA recordkeeping rulemaking; and increased adoption of international safety standard, ISO 45001.

  • Get the Ultimate Guide to OSHA Recordkeeping

    OSHA’s Form 300A posting deadline is February 1! Are you prepared? To help answer your key recordkeeping questions, IndustrySafe put together this guide with critical compliance information.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe

OH&S Digital Edition

  • OHS Magazine Digital Edition - January 2019

    January 2019

    Featuring:

    • PREVENTING ERRORS
      Production vs. Safety 
    • EMERGENCY SHOWERS & EYEWASH
      Meeting the Requirements for Emergency Equipment
    • CONSTRUCTION SAFETY
      The State of Contractor Safety
    • FOOT PROTECTION
      The Three Keys to Effective Chemical Management
    View This Issue