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2291. Women's health care and contraceptive practices in Mississippi: technical report

Author(s):
Kolbo, Jerome R., author
Ismail, Olivia, author
McLeod, Stephanie, author
Bradwell, Morgan, author
Funchess, Tanya, author
Zhang, Lei, author
Publication:
Jackson, MS : Center for Mississippi Health Policy, July 2019
Subject(s):
Contraception -- statistics & numerical data
Contraception Behavior -- statistics & numerical data
Contraceptive Agents, Female -- therapeutic use
Contraceptive Devices, Female -- statistics & numerical data
Reproductive Health Services -- statistics & numerical data
Women's Health Services
Adolescent
Adult
Contraception -- economics
Contraception Behavior -- ethnology
Health Services Accessibility
Insurance Coverage
Middle Aged
Parity
Pregnancy
Pregnancy, Unplanned
State Government
Humans
Mississippi
United States

2292. Coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 1, 2019
Subject(s):
Anti-Infective Agents
Device Approval
Drug Approval
Drug Development
Microbial Sensitivity Tests
Drug Industry
Biotechnology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2295. Intent to exempt certain unclassified medical devices from premarket notification requirements: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, June 14, 2019
Subject(s):
Device Approval
Equipment and Supplies -- classification
Gastroenterology -- instrumentation
Gynecology
Obstetrics -- instrumentation
Otolaryngology -- instrumentation
Physical and Rehabilitation Medicine -- instrumentation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2298. 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.

2299. 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.

2300. 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.