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21. 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

22. 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

23. 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

24. 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.

25. 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.

26. 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

27. 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

28. 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

29. Pediatric information incorporated into human prescription drug and biological product labeling

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):: Drug Labeling -- standards
Pediatrics
Product Labeling -- standards
Adolescent
Biological Products
Child
Child, Preschool
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

30. Considerations in demonstrating interchangeability with a reference product

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):: Biosimilar Pharmaceuticals -- standards
Drug Substitution
Proteins -- therapeutic use
Biological Products
Clinical Trials as Topic
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.