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Start Over Subjects Biological Products -- standards ✖Remove constraint Subjects: Biological Products -- standards Genre Technical Report ✖Remove constraint Genre: Technical Report

1. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation -- standards
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, November 2017
Subject(s):
Autografts -- standards
Biological Products -- standards
Biological Products -- therapeutic use
Tissue Transplantation
Transplantation, Autologous
Transplantation, Homologous
Transplants -- standards
Prostheses and Implants -- standards
Surgical Procedures, Operative
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. CMC postapproval manufacturing changes for specified biological products to be documented in annual reports

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2021
Subject(s):
Annual Reports as Topic
Biological Products -- standards
Biological Products -- supply & distribution
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. Medical devices containing materials derived from animal sources (except for in vitro diagnostic devices): guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, March 15, 2019
Subject(s):
Biological Products -- standards
Device Approval -- standards
Equipment and Supplies -- standards
Disease Transmission, Infectious -- prevention & control
Encephalopathy, Bovine Spongiform -- transmission
Sterilization -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):
Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States