Product Classification - Food and Drug Administration
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Contact the FDA Import Program
For questions on a detained or refused entry: Contact the compliance officer listed on the last page of the Notice of FDA Action (NOA). Note: You can obtain NOAs via ITACS with an ITACS...
FDA Roundup: September 15, 2023
Sep 15, 2023 · Today, the FDA issued the draft guidance “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” and corresponding Notice of Availability (NOA).
FDA Acronyms & Abbreviations
Search the FDA Acronyms and Abbreviations database About This Database The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related …
The NOA will include links to the web pages on which each Center/Office guidance agenda is posted and provide clear information on how interested parties may submit comments to each …
Examination & Sample Collection | FDA
Nov 4, 2025 · Examination & Sample CollectionThe FDA has the authority to conduct examinations and/or sample collections to determine if the product offered for import is in …
Actions & Enforcement | FDA
Sep 10, 2024 · This page describes FDA import actions and enforcement such as, import alerts, filer evaluations, etc.
The Agency posts draft Level 1 guidances on its website, and it publicizes them by issuing a Notice of Availability (NOA) of the draft guidance in the Federal Register.
FDA Releases Two Draft Guidances, Seeks Public Comment on Pre …
Jan 6, 2025 · To submit an electronic comment, visit docket FDA-2024-N-2979. Instructions for submitting comments can be found in the Federal Register NOA. Public Listening Sessions
Between 2005 and 2010, FDA annually published between 89 and 121 guidance documents with an accompanying NOA (average 101 per year).