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Start Over Subjects Biological Products ✖Remove constraint Subjects: Biological Products

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.

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.

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.

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.

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.

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

31. 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.

32. 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.

33. Osteoporosis: nonclinical evaluation of drugs intended for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Bone Density Conservation Agents -- therapeutic use
Drug Evaluation, Preclinical -- standards
Osteoporosis -- drug therapy
Anabolic Agents
Biological Products
Bone Density
Research Design
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

34. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

35. Adaptive designs for clinical trials of drugs and biologics

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Adaptive Clinical Trials as Topic -- standards
Investigational New Drug Application
Adaptive Clinical Trials as Topic -- ethics
Biological Products
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

37. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):
Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States

38. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):
Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.