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4772. 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

4773. Center for Devices and Radiological Health (CDRH) appeals processes: Guidance for industry and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 2, 2022
Subject(s):
Device Approval -- legislation & jurisprudence
Dissent and Disputes
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4775. Current good manufacturing practice and preventive controls, foreign supplier verification programs, intentional adulteration, and produce safety regulations: enforcement policy regarding certain provisions

Publication:
[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, March 2022
Subject(s):
Agriculture
Animal Feed -- supply & distribution
Food Handling -- legislation & jurisprudence
Food Safety
Food Supply -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4776. Initiation of voluntary recalls under 21 CFR Part 7, subpart C: guidance for industry and FDA staff

Publication:
Rockville, MD : Office of Regulatory Affairs, March 2022
Subject(s):
Drug Recalls -- legislation & jurisprudence
Medical Device Recalls -- legislation & jurisprudence
Product Recalls and Withdrawals -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4778. 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