💊FDA Seeks Comments on Drug Safety Technology Meeting Program
Agency Information Collection Activities; Proposed Collection; Comment Request; Emerging Drug Safety Technology Meeting Program
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Emerging Drug Safety Technology Meeting (EDSTM) Program.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's proposed collection of information through the Emerging Drug Safety Technology Meeting program requires businesses, particularly those in the pharmaceutical industry, to engage in commentary and presentations regarding their use of AI in pharmacovigilance. This poses regulatory compliance requirements and potential impacts on business operations and strategies.