1. Manufacturing, supply chain, and drug and biological product inspections during COVID-19 public health emergency: questions and answers Publication: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 17, 2021 Subject(s): Biological ProductsCOVID-19Drug IndustryQuality ControlUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
2. S11 nonclinical safety testing in support of development of pediatric pharmaceuticals Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021 Subject(s): Drug CompoundingDrug IndustryPediatricsPharmaceutical PreparationsQuality ControlUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
3. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management: annexes Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021 Subject(s): Drug IndustryQuality ControlUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration
4. Q12 technical and regulatory considerations for pharmaceutical product lifecycle management Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021 Subject(s): Drug IndustryQuality ControlUnited StatesUnited States. Department of Health and Human ServicesUnited States. Food and Drug Administration