FDA issues draft guidance for industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM630099.pdf?utm_campaign=SBIA%3A%20FDA%20issues%20draft%20guidance%20for%20industry%2C%20Marketing%20Status%20Notifications&utm_medium=email&utm_source=Eloqua&elqTrackId=B168397BEBB4552472872BFDAD1FA53A&elq=e9ea3eb2c26b4e6989c03422ad6ad629&elqaid=6555&elqat=1&elqCampaignId=5359

On January 30, 2019, the FDA published notice of a draft guidance for industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format. The FDA Reauthorization Act of 2017 (FDARA), enacted on August 18, 2017, added section 506I to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 506I imposes additional reporting requirements on new drug application (NDA) and abbreviated new drug application (ANDA) holders regarding the marketing status of approved products, including: Notification of withdrawal from sale, which requires NDA and ANDA holders to provide a written notification to FDA 180 days prior to withdrawing an approved drug from sale Notification of drug not available for sale, which requires NDA and ANDA holders to provide a written notification to FDA within 180 days of the date of approval of a drug if that drug will not be available for sale within 180 days of the date of approval One-time report on marketing status, which required NDA and ANDA holders to provide a written notification to FDA within 180 days of enactment of FDARA stating whether the NDA and ANDA holder’s drug(s) in the active section of the Orange Book are available for sale or if one or more of the NDA or ANDA holder’s drugs in the active section have been withdrawn from sale or have never been available for sale (this requirement was previously announced ahead of the February 14, 2018 deadline) To comment on the guidance, please visit the public docket, FDA-2018-D-4615. Direct link to the guidance: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM630099.pdf