1. Failure to respond to an ANDA complete response letter within the regulatory timeframe Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022 Subject(s): Correspondence as TopicDrug ApprovalGovernment RegulationUnited StatesUnited States. Food and Drug Administration
2. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023 Subject(s): Correspondence as TopicDrug ApprovalDrug IndustryDrugs, GenericGovernment RegulationUnited StatesUnited States. Food and Drug Administration
3. Notifying FDA of a permanent discontinuance or interruption in manufacturing of a device under Section 506J of the FD&C Act: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, November 17, 2023 Subject(s): Correspondence as TopicDevice ApprovalGovernment RegulationManufacturing IndustryUnited StatesUnited States.
