FDA News: Issue 4-1, May 2024

Author: [AUTHOR] Published on 5/15/2024 4:00:00 PM

FDA’s SBIA Webinar on Statistical Considerations for Premarketing Risk Assessment

On May 16, 2024, the FDA Center for Drug Evaluation and Research (CDER)’s Small Business and Industry Assistance (SBIA) will host a webinar entitled Statistical Considerations for Premarketing Risk Assessment. This event will describe important statistical considerations in the premarketing assessment of drug safety; cover the importance of planning for the safety assessment of a drug and address statistical considerations in the analysis of safety data, primarily adverse event data.

Topics Covered:

  • How trial design can enhance the assessment of safety data
  • The importance of tailoring the analysis of safety to align with trial design
  • The use of appropriate statistical analysis approaches, including topics such as the choice of metric for estimating risk, handling treatment discontinuation, and integrated analyses

May 16th, 2024
1:00 PM – 2:30 PM ET

Additional Details:
Attendance is virtual, and continuing education credits are available. The webinar is free, but registration is required. For more information on this webinar, including specific topics to be covered, agenda, and intended audience, please visit the meeting website.

CDER’s SBIA aims to help small pharmaceutical business and industry navigate the wealth of information that FDA offers and assist in understanding human drug product regulation. To learn more about CDER’s SBIA, visit their website.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today or click the button below select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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