Search

671. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017

Subject(s):

Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

672. Use of serological tests to reduce the risk of transfusion-transmitted human T-lymphotropic virus types I and II (HTLV-I/II)

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, February 2020

Subject(s):

Blood Transfusion -- standards
HTLV-I Antibodies -- blood
HTLV-II Antibodies -- blood
HTLV-I Infections -- transmission
HTLV-II Infections -- transmission
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

673. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017

Subject(s):

Blood Donors
Chagas Disease -- blood
Chagas Disease -- transmission
Disease Transmission, Infectious -- prevention & control
Donor Selection
Serologic Tests
Trypanosoma cruzi
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

674. 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
Organ Preservation -- instrumentation
Organ Preservation -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

675. Variation in interoperability among U.S. non-federal acute care hospitals in 2017

Author(s):

Pylypchuk, Yuriy, author
Johnson, Christian, MPH, author
Henry, JaWanna, author
Ciricean, Diana, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, November 2018

Subject(s):

Electronic Health Records -- statistics & numerical data
Health Information Interoperability -- statistics & numerical data
Hospitals -- statistics & numerical data
Information Dissemination
United States
United States. Department of Health and Human Services

676. Variation in methods for health information management among U.S. substance abuse treatment centers: 2017

Author(s):

Barker, Wesley, author
Christian Johnson, MPH, author

Publication:

Washington, DC : U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, July 2020

Subject(s):

Electronic Health Records -- statistics & numerical data
Health Information Management -- methods
Information Dissemination -- methods
Substance Abuse Treatment Centers -- statistics & numerical data
United States
United States. Department of Health and Human Services

677. Voluntary sodium reduction goals: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods

Publication:

[Silver Spring, MD] : Center for Food Safety and Applied Nutrition, October 2021

Subject(s):

Food Handling
Food-Processing Industry
Sodium, Dietary
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

678. Vulvovaginal candidiasis: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, August 2019

Subject(s):

Candidiasis, Vulvovaginal -- drug therapy
Clinical Trials as Topic -- standards
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

679. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, December 2017

Subject(s):

Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

680. Weaknesses exist in Medicaid managed care organizations' efforts to identify and address fraud and abuse

Publication:

[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, July 2018

Subject(s):

Fraud -- prevention & control
Managed Care Programs
Medicaid
United States
United States. Department of Health and Human Services