Zdrowie i gospodarka · 05/07/2019

FDA Corrects Notice on Electronic Regulatory Submissions

The Food and Drug Administration is correcting a notice regarding the availability of a guidance for industry related to electronic submissions of regulatory documents, specifically the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling. The agency corrected an error in the docket number of the previously published document, and previously submitted comments will be transferred to the correct docket number.