Search

1. The "deemed to be a license" provision of the BPCI Act: questions and answers

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, March 2020

Subject(s):

Biological Products
Drug Approval
Licensure
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. 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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.

3. 340B Drug Discount Program: oversight of the Intersection with the Medicaid Drug Rebate Program needs improvement : report to Congressional requesters

Publication:

Washington, DC : United States Government Accountability Office, January 2020

Subject(s):

Drug Costs -- legislation & jurisprudence
Government Regulation
Medicaid -- economics
United States
United States. Department of Health and Human Services

4. 510(k) third party review program: guidance for industry, Food and Drug Administration staff, and third party review organizations

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, March 12, 2020

Subject(s):

Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. ACF cannot ensure that all child victims of abuse and neglect have court representation

Publication:

Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, March 2021

Subject(s):

Child Abuse -- legislation & jurisprudence
Child Protective Services -- standards
Government Regulation
Legal Services -- organization & administration
United States
United States. Department of Health and Human Services

6. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, July 2018

Subject(s):

Drugs, Generic -- standards
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

7. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2020

Subject(s):

Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

8. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2021

Subject(s):

Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Acceptance and filing reviews for premarket approval applications (PMAs): guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Biologics Evaluation and Research, December 16, 2019

Subject(s):

Device Approval -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

10. Access and use of electronic health information by individuals with cancer: 2017-2018

Author(s):

Johnson, Christian, MPH, author
Krakow, Melinda, author
Patel, Vaishali, author

Publication:

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

Subject(s):

Electronic Health Records -- statistics & numerical data
Facilities and Services Utilization -- statistics & numerical data
Health Services Accessibility -- statistics & numerical data
Neoplasms
United States
United States. Department of Health and Human Services