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181. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):
Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

182. Unique device identification: policy regarding compliance dates for class I and unclassified devices : immediately in effect guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, January 16, 2018
Subject(s):
Equipment and Supplies -- classification
Product Labeling -- standards
Product Packaging -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

183. Compounded drug products that are essentially copies of a commercially available drug product under Section 503A of the Federal Food, Drug, and Cosmetic Act

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):
Drug Compounding -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

186. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

187. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
Subject(s):
Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

188. Physician workforce: locations and types of graduate training were largely unchanged, and federal efforts may not be sufficient to meet needs : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, May 2017
Subject(s):
Education, Medical, Graduate -- statistics & numerical data
Health Manpower
Physicians, Family -- education
Physicians, Family -- supply & distribution
Primary Health Care -- manpower
Education, Medical, Graduate -- trends
Forecasting
Medicine -- statistics & numerical data
Nurse Practitioners -- supply & distribution
Physician Assistants -- supply & distribution
Rural Health Services -- manpower
Urban Health Services -- manpower
Humans
United States
United States. Department of Health and Human Services.

189. Hospital value-based purchasing: CMS should take steps to ensure lower quality hospitals do not qualify for bonuses : report to Congressional committees

Publication:
Washington, D.C. : U.S. Government Accountability Office, June 2017
Subject(s):
Economics, Hospital
Quality of Health Care
Reimbursement, Incentive
Value-Based Purchasing
Hospitals, Rural -- economics
Hospitals, Urban -- economics
Safety-net Providers -- economics
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

190. Early learning and child care: agencies have helped address fragmentation and overlap through improved coordination : report to the Chairwoman, Committee on Education and the Workforce, House of Representatives

Publication:
Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):
Early Intervention (Education) -- economics
Early Intervention (Education) -- organization & administration
Education, Special
Child Development
Child, Preschool
Disabled Children -- education
Financing, Government
Government Programs
Schools, Nursery
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Labor.
United States. Department of the Interior.