11. Competitive generic therapies Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020 Subject(s): Drug ApprovalDrugs, GenericInvestigational New Drug ApplicationUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
12. 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