On January 30, 2019 the FDA published a draft guidance for industry, Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format.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 ADNA 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Orange Book are available for sale or if one or more of the NDA or ANDA holder’s drugs in the active section have been withdrawn from sale or have never been available for sale (this requirement was previously announced ahead of the February 14, 2018 deadline)
We are posting this document on the FDA website as Federal Register (FR) publication is not currently available for this document. This posting is to provide advance notice to the public. When publication in the FR becomes available, a notice will be available in the FR which will also detail how to submit comments on this document. |
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