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Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is requesting comments on the topics discussed at a public workshop entitled “Advancing Premarket Safety Analytics Workshop” held on September 14, 2022. The purpose of the public workshop was to present FDA's work and perspective on premarket review of safety data.
Either electronic or written comments on this public workshop must be submitted by December 5, 2022. See the SUPPLEMENTARY INFORMATION section for information.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 5, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2022-N-1961 for “Advancing Premarket Safety Analytics Workshop.” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
Christopher Smith, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6230, Silver Spring, MD 20993, 301-796-4851, christopher.smith2@fda.hhs.gov.
Because of a lack of standardization of safety data analysis and visualization, inconsistencies have been noted in how adverse events are defined, categorized, analyzed, and presented in marketing applications. The FDA Center for Drug Evaluation and Research's (CDER's) ( printed page 66307) Office of New Drugs (OND) led the development of two documents to facilitate internal review of safety data. The first document, “FDA Medical Queries,” provides a standardized approach to group preferred terms of adverse events using “Medical Dictionary for Regulatory Activities” (MedDRA) terminology. The second document, “Standard Safety Tables and Figures Integrated Guide,” provides standardized methods for visualization of clinical trial safety data into tables and figures. FDA values transparency and collaboration with external stakeholders; therefore, both documents are available for public comment through the docket.
At the public workshop entitled “Advancing Premarket Safety Analytics Workshop,” CDER's OND presented its work and perspective related to safety analytics. The workshop provided presentations from FDA staff on the two documents “FDA Medical Queries” and “Standard Safety Tables and Figures Integrated Guide ” (meeting materials available at https://healthpolicy.duke.edu/events/advancing-premarket-safety-analytics). The workshop also included panel discussions with industry representatives on “Stakeholder Perspectives Exploring Premarket Adverse Event Grouping” and “Examining Strategies for Adverse Event Analysis.” FDA documents were intended as a starting point for broader discussions on best practices and innovative approaches for advancing premarket safety signal analytics. We are also seeking comment on the topics discussed at the workshop.
Dated: October 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23925 Filed 11-2-22; 8:45 am]
BILLING CODE 4164-01-P
5 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.