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ISO 19600, Compliance management systems - Guidelines, is a compliance standard introduced by the International Organization for Standardization (ISO) in April 2014. As its title suggests, it operates as an advisory standard and is not used for accreditation or certification.
The Medicaid Drug Rebate Program provides for mandatory rebates on innovator drugs (e.g., brand drugs), blood clotting factors, drugs Food and Drug Administration-approved exclusively for pediatric indications, and non-innovator drugs (e.g., generic drugs). [1] The maximum rebate is capped at 100% of the Average Manufacturer Price (AMP).
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
Readiness for enhanced therapeutic regimen management is a NANDA approved nursing diagnosis which is defined as "A pattern of regulating and integrating into daily living a program(s) for treatment of illness and its sequelae that is sufficient for meeting health-related goals and can be strengthened."
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program is a program that grants a voucher for priority review to a drug developer as an incentive to ...
Medicare Part D, also called the Medicare prescription drug benefit, is an optional United States federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs. [1] Part D was enacted as part of the Medicare Modernization Act of 2003 and went into effect on January 1, 2006. Under the program, drug ...
Diagnosis-related group (DRG) is a system to classify hospital cases into one of originally 467 groups, [1] with the last group (coded as 470 through v24, 999 thereafter) being "Ungroupable". This system of classification was developed as a collaborative project by Robert B Fetter, PhD, of the Yale School of Management , and John D. Thompson ...