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VOOZH | about |
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VOOZH | about |
OTC Monographs@FDA provides a resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs. OTC Monographs@FDA also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified.
Some final orders incorporate by reference material that is available for inspection at FDA. For further information about inspecting incorporated material, contact druginfo@fda.hhs.gov.
To learn more about OTC monographs and find answers to common questions on this topic, visit the frequently asked questions.
Nonbinding list of planned OTC monograph activities that FDA intends to address over the next 3 years
Guidance documents, presentations, meeting minutes, and regulatory information
FDA provides updates on the OMUFA user fee program, including arrears and paid facilities lists, which are available under the "OMUFA Arrears and Paid Facilities Lists" tab.
Learn more about monographs and answers to frequently asked questions.
Search proposed, interim final, or final administrative orders including supporting documents and public comments
Comment on administrative orders with open comment periods
