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21. 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 Products
COVID-19
Drug Industry
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

22. 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

23. 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

24. 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

25. 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

26. The "deemed to be a license" provision of the BPCI Act: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Biological Products
Drug Approval
Licensure
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

27. Biological product deviation reporting for blood and plasma establishments

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, March 2020
Subject(s):: Biological Products
Blood Banks -- standards
Mandatory Reporting
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

28. 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

29. 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

30. 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