Determining Whether To Submit an ANDA or a 505(b)(2) Application; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application." This draft guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. This draft guidance revises the guidance for industry titled "Determining Whether to Submit an ANDA or a 505(b)(2) Application" issued in May 2019 and, when finalized, will replace the 2019 guidance for industry.
Read the official notice →Source: Federal Register (FDA/USDA food labeling) · US Government work (public domain). This is a short, attributed summary; the full authoritative text lives on the authority’s own site. LabelYog does not author or endorse it — confirm compliance against the destination market’s official source.
More from United States
- Testosterone Use in Menopausal Women; Public Workshop; Request for Comments regulatory
- Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate regulatory
- National Organic Program: Notice of Intent To Extend a Previously Approved Information Collection (Strengthening Organic Enforcement) (2026) regulatory
- Carboxin; Pesticide Tolerances regulatory
- Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I regulatory
- Schedules of Controlled Substances: Temporary Placement of 5,6-Dichloro Brorphine, 5,6-Dichloro Desmethylchlorphine, N-Propionitrile Chlorphine, and Spirochlorphine in Schedule I of the Controlled Substances Act regulatory
What this means for your label
A notice like this changes what a pack must carry. These are the rules we build against, starting with US FDA.