FDA Announces Improved Transparency, Public Disclosure Policies

The Food and Drug Administration yesterday announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. FDA announced the availability of the guidance documents in the Aug. 4, 2008 Federal Register; copies of all of the guidances are available on FDA's Web site. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days.

"The FDA's regulatory decisions affect the health of millions of Americans, and we don't make those decisions in a vacuum," said Randall Lutter, Ph.D., deputy commissioner for policy. "It's imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. [Yesterday's] announcement strengthens our processes."

Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings. Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations.

Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. As detailed in the final guidance on advisory committee briefing materials, FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA's Web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also recommends a timetable that sponsors should follow when submitting such documents.

For more information, go to www.fda.gov.

Download Center

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

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    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 FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - May 2019

    May 2019

    Featuring:

    • RESPIRATORY PROTECTION
      Why Pick a PAPR? 
    • FIRE SAFETY TRAINING
      Fire Safety: Plan, Prevent, Train, Recover
    • PROTECTIVE APPAREL
      The Truth About Heat Stress and FRC
    • AIHCE EXP 2019 PREVIEW
      Underestimated No More
    View This Issue