Type:Notice
Citation:90 FR 13371
Reading Time:about 22 minutes
The Food and Drug Administration (FDA) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.
Simple Explanation
The FDA is charging some companies that make over-the-counter medicines a fee for fiscal year 2025. This helps them pay for keeping an eye on these medicines to make sure they're safe.