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1. 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.

2. 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.

3. Utilizing animal studies to evaluate organ preservation devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, May 8, 2019
Subject(s):
Device Approval -- standards
Evaluation Studies as Topic
Organ Preservation -- instrumentation
Organ Preservation -- standards
Perfusion -- instrumentation
Reperfusion -- instrumentation
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
Carcinogenicity Tests
Drug Labeling
Lactation -- drug effects
Pharmacokinetics
Radiation Dosage
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. 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.

6. Investigational enzyme replacement therapy products: nonclinical assessment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Enzyme Replacement Therapy -- standards
Models, Animal
Research Design
Safety
Toxicity Tests -- standards
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Smallpox (variola virus) infection: developing drugs for treatment or prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
Subject(s):
Clinical Trials as Topic
Drug Development -- standards
Smallpox -- drug therapy
Smallpox -- prevention & control
Antiviral Agents -- pharmacology
Antiviral Agents -- therapeutic use
Drug Evaluation, Preclinical
Emergencies
Investigational New Drug Application
Models, Animal
Orthopoxvirus
Public Health
Research Design
Safety
Toxicity Tests
Variola virus
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.