Subjects: Biological Products and United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

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11. Chemistry, manufacturing, and controls changes to an approved application: certain biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Biological Products
Drug Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

12. Principles of premarket pathways for combination products: guidance for industry and FDA Staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2022
Subject(s):: Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

13. Reporting amount of listed drugs and biological products technical conformance guide

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2021
Subject(s):: Biological Products
Drug Industry
Drug Labeling
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

14. Providing regulatory submissions in alternate electronic format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2021
Subject(s):: Biological Products
Drug Approval
Drug Development
Electronic Mail
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

15. Nonclinical considerations for mitigating nonhuman primate supply constraints arising from the COVID-19 pandemic

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2022
Subject(s):: Biological Products
Drug Evaluation, Preclinical
Primates
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. Expansion cohorts: use in first-in-human clinical trials to expedite development of oncology drugs and biologics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Antineoplastic Agents
Biological Products
Clinical Trials as Topic
Drug Development -- legislation & jurisprudence
Drug Development -- standards
Medical Oncology
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

17. Master protocols: efficient clinical trial design strategies to expedite development of oncology drugs and biologics

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2022
Subject(s):: Antineoplastic Agents
Biological Products
Clinical Trial Protocols as Topic
Clinical Trials as Topic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration