Subjects: Biological Products - Digital Collections - National Library of Medicine Search Results

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1. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Economic analysis of availability of follow-on protein products: final report

Publication:: [Washington, DC] : Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, 2009
Subject(s):: Proteins -- economics
Biological Products
Drug Approval -- economics
United States

3. I.G. Farbenindustrie A.G., Abteilung: Behring Werke, Marburg a.d. Lahn, Germany

Author(s):: Chinard, Francis T., author
Horack, Harold Maclachlan, 1912-1977, author
Wuebner, Richard A., author
Leaper, Percy J., author
Smadel, Joseph E. (Joseph Edwin), 1907-1963, author
Publication:: [London?] : Combined Intelligence Objective Sub-Committee, [1945]
Subject(s):: Chemical Industry
Biological Products
Vaccines
World War II
Germany
Interessengemeinschaft Farbenindustrie Aktiengesellschaft.

4. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. M10: bioanalytical method validation and study sample analysis : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Biological Products
Chemistry Techniques, Analytical
Government Regulation
Methods
United States
United States. Food and Drug Administration

6. Format and content of a REMS document: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Biological Products
Consumer Product Safety -- legislation & jurisprudence
Drug Industry
Government Regulation
Risk Evaluation and Mitigation
United States
United States. Food and Drug Administration

7. Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States

8. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

9. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

10. Instructions for use: patient labeling for human prescription drug and biological products : content and format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Government Regulation
Prescription Drugs
Product Labeling
United States
United States. Food and Drug Administration

11. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

12. Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration

13. 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 Biologics Evaluation and Research, July 2020
Subject(s):: Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Good manufacturing practice considerations for responding to COVID-19 infection in employees in drug and biological products manufacturing

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):: Biological Products
COVID-19 -- prevention & control
Drug Industry
Manufacturing and Industrial Facilities
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. COVID-19: developing drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2021
Subject(s):: Biological Products
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Drug Industry
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. COVID-19 public health emergency: general considerations for pre-IND meeting requests for COVID-19 related drugs and biological products : guidance for industry and investigators

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, May 2020
Subject(s):: Biological Products
COVID-19 -- drug therapy
Drug Approval
Drug Industry
Drugs, Investigational
Drug Evaluation, Preclinical
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Resuming normal drug and biologics manufacturing operations during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, September 2020
Subject(s):: Biological Products
Drug Industry
Manufacturing and Industrial Facilities
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Importation of certain FDA approved human prescription drugs, including biological products, and combination products under section 801(d)(1)(b) of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Biological Products
Drug Labeling
Prescription Drugs
Counterfeit Drugs
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Requesting FDA feedback on combination products: guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2020
Subject(s):: Biological Products
Formative Feedback
Legislation, Drug
Medical Device Legislation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

20. COVID-19: master protocols evaluating drugs and biological products for treatment or prevention

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Biological Products
Clinical Trial Protocols as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration