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4783. Opioid use disorder: developing depot buprenorphine products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2019
Subject(s):
Buprenorphine -- therapeutic use
Drug Development
Opioid-Related Disorders -- drug therapy
Buprenorphine -- administration & dosage
Clinical Trials as Topic
Delayed-Action Preparations
Narcotic Antagonists
Opiate Substitution Treatment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4784. Evaluation of devices used with regenerative medicine advanced therapies

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Regenerative Medicine -- classification
Regenerative Medicine -- instrumentation
Biological Products -- classification
Cell- and Tissue-Based Therapy -- classification
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4785. Considerations for the inclusion of adolescent patients in adult oncology clinical trials

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic -- ethics
Adolescent
Neoplasms -- drug therapy
Adult
Medical Oncology -- ethics
Patient Safety
Patient Selection
Pharmacokinetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4786. Severely debilitating or life-threatening hematologic disorders: nonclinical development of pharmaceuticals

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Hematologic Diseases -- drug therapy
Animals
Carcinogenicity Tests
Cytotoxicity Tests, Immunologic
Drug Therapy, Combination
Drug-Related Side Effects and Adverse Reactions
Immunologic Tests
Mutagenicity Tests
Pediatrics
Pharmacokinetics
Photochemistry
Safety
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4787. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic
Prognosis
Research Design
Biomarkers, Pharmacological
Biomarkers, Tumor
Captopril -- therapeutic use
Cardiovascular Diseases -- drug therapy
Clozapine -- therapeutic use
Cyclooxygenase 2 Inhibitors -- therapeutic use
Drugs, Investigational
Lung Diseases -- drug therapy
Medication Adherence
Neoplasms -- drug therapy
Patient Compliance
Patient Selection
Pharmacogenetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4788. 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.

4789. Pediatric HIV infection: drug product development for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Development -- standards
HIV Infections -- drug therapy
Pediatrics
Adolescent
Anti-Retroviral Agents -- therapeutic use
Child
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4790. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Drug Development
HIV Infections -- prevention & control
Pre-Exposure Prophylaxis
Adolescent
Child
Clinical Trials as Topic
HIV Infections -- drug therapy
HIV-1
Infant
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.