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FDA Wants Public Input on How to Improve Drug Safety

Posted 19 March 2015 | By Alexander Gaffney, RAC

FDA Wants Public Input on How to Improve Drug Safety

If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up.

In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products.

The center regularly identifies potential priorities of its own. For example, it regularly publishes a "guidance agenda" containing all of the draft and final policy documents it plans to work on throughout the coming calendar year. Each year it also publishes a "Broad Agency Announcement" detailing which regulatory science projects it hopes to fund, given the right contracting partners. And CDER also regularly asks for feedback on prioritization within specific policies, such as how to prioritize the review of generic drugs.

What CDER wants now, it says, is some public input on its regulatory priorities.

The agency's Safety Research Interest Group (SRIG) recently identified seven "overall needs for drug safety-related regulatory science," CDER wrote in its Federal Register notice.

Those needs are:

  1. improve access to postmarket data sources and explore the feasibility of their use in safety signal analyses
  2. improve risk assessment and management strategies to reinforce the safe use of drugs
  3. evaluate the effectiveness of risk communications of drug safety information to health care providers and the public
  4. improve product quality and design, manufacturing processes, and product performance relating to safety
  5. develop and improve predictive models of safety in humans, including nonclinical biomarkers
  6. improve clinical trial statistical analyses for safety, including benefit-risk assessment
  7. investigate clinical biomarkers of safety, including standards for qualification.

CDER said some of these needs will require "further resources and outside participation," including collaboration with external partners and stakeholders.

Accordingly, the agency is asking outside groups to "submit descriptions of their ongoing research and initiatives" related to CDER's identified needs, and indicate whether or not they are interested in working with FDA to address those needs.


Federal Register Announcement

Federal Docket

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