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5031. Interpretation of and compliance policy for certain label requirement: applicability of certain Federal Food, Drug, and Cosmetic Act requirements to vape shops

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Electronic Nicotine Delivery Systems -- standards
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Product Labeling -- standards
Vaping -- legislation & jurisprudence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5032. Standards development and the use of standards in regulatory submissions reviewed in the Center for Biologics Evaluation and Research

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, March 2019
Subject(s):
Guidelines as Topic
Consensus
Device Approval
Drug Approval
Government Agencies
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Center for Biologics Evaluation and Research (U.S.)

5033. 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.

5034. Recommended content and format of non-clinical bench performance testing information in premarket submissions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 20, 2019
Subject(s):
Device Approval -- standards
Materials Testing -- standards
Equipment and Supplies -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5035. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5036. REMS: FDA's application of statutory factors in determining when a REMS is necessary

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Drug Evaluation -- legislation & jurisprudence
Risk Evaluation and Mitigation -- legislation & jurisprudence
Cost of Illness
Drug-Related Side Effects and Adverse Reactions
Health Services Accessibility
Prescription Drugs -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5037. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5038. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019
Subject(s):
Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
Bacteriophage Typing -- classification
Enzyme-Linked Immunosorbent Assay -- classification
Fluorescent Antibody Technique -- classification
Nucleic Acid Amplification Techniques -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5039. 30-Day notices, 135-day premarket approval (PMA) supplements and 75-day humanitarian device exemption (HDE) supplements for manufacturing method or process changes: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 16, 2019
Subject(s):
Device Approval -- standards
Equipment and Supplies -- standards
Manufactured Materials -- standards
Device Approval -- legislation & jurisprudence
Time Factors
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

5040. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, April 26, 2019
Subject(s):
Equipment and Supplies -- standards
Product Labeling -- standards
Equipment Reuse
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.