1. General clinical pharmacology considerations for neonatal studies for drugs and biological products Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022 Subject(s): Biological ProductsClinical Studies as TopicDrug DevelopmentGovernment RegulationInfant HealthPharmacology, ClinicalUnited StatesUnited States. Food and Drug Administration
2. Procedures for handling post-approval studies imposed by premarket approval application order: guidance for industry and Food and Drug Administration staff Publication: [Silver Spring, MD] : Center for Devices and Radiological Health, October 7, 2022 Subject(s): Clinical Studies as TopicDevice ApprovalGovernment RegulationUnited StatesUnited States. Food and Drug Administration
3. Human gene therapy for neurodegenerative diseases: guidance for industry Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2022 Subject(s): Clinical Studies as TopicGenetic Therapy -- legislation & jurisprudenceGovernment RegulationNeurodegenerative Diseases -- therapyUnited StatesUnited States. Food and Drug Administration
