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1. Potential misclassifications reported by drug manufacturers may have led to $1 billion in lost Medicaid rebates

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2017
Subject(s):
Drug Costs
Drug Industry -- economics
Medicaid -- economics
Pharmaceutical Preparations -- classification
Pharmaceutical Preparations -- economics
Insurance, Health, Reimbursement
Insurance, Pharmaceutical Services
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

2. How to prepare a pre-request for designation (pre-RFD)

Publication:
[Silver Spring, Maryland] : Office of Combination Products, Office of the Commissioner, February 2018
Subject(s):
Equipment and Supplies -- classification
Drugs, Investigational -- classification
Investigational New Drug Application
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Classification of products as drugs and devices & additional product classification issues: final guidance : guidance for industry and FDA staff

Publication:
Silver Spring, MD : Office of Combination Products, Food and Drug Administration, September 2017
Subject(s):
Biological Products -- classification
Classification -- methods
Equipment and Supplies -- classification
Pharmaceutical Preparations -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.