3 Feb 2025
💊FDA Proposes New Labeling Requirements for Prescription Drugs
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs
Summary
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines compliance and regulatory requirements for labeling prescription drugs under FDA regulations. Business owners and executives in the pharmaceutical industry must adhere to these new information collection requirements to avoid penalties and ensure successful drug approval, directly impacting operational processes and costs.