Study Set Content:
are not allowed in black box warnings
Advertisements or “reminder ads”
Each firm must register with the FDA and submit information
Drug Listing Act of 1972
Enacted to provide the FDA with the legislative authority to compile a list of marketed drugs
Drug Listing Act of 1972
exemptions of drug listing Act of 1972
Compounded Preparations Research products
Drug Listing Act of 1972 introduced
National Drug Code number system
Hasten FDA approval • Extend patent life
Drug Price Competition and Patent Term Restoration Act of 1984
ANDA) means
Abbreviated new drug application
• Abbreviated new drug application (ANDA)
Drug Price Competition and Patent Term Restoration Act of 1984
To reduce the risks of adulterated, misbranded, repackaged, or mislabelled drugs
Prescription Drug Marketing Act of 1987 and Amendments
Prescription Drug Marketing Act of 1987 and Amendments made?
Reimportation • Sales restrictions • Sample distribution • Wholesale distributors
DSHEA
Dietary Supplement Health and Education Act of 1994
Dietary Supplement Health and Education Act of 1994 included
Herbs and dietary supplements, including vitamins, minerals, amino acids, botanicals
Labeling claims regulations
Dietary Supplement Health and Education Act of 1994
Not legally considered drugs
Dietary Supplement Health and Education Act of 1994
USP-NF standards
Dietary Supplement Health and Education Act of 1994
The FDA Modernization Act of 1997 and Amendments of 2007 created
The Center for Drug Evaluation and Research (CDER) • The Center for Biologics Evaluation and Research (CBER)
• Streamline FDA policies and codify regulations
The FDA Modernization Act of 1997 and Amendments of 2007
• Guidelines and regulations
The FDA Modernization Act of 1997 and Amendments of 2007
Drug Product Recall classes
CLASS 1
CLASS 2
CLASS 3
May cause temporary or medically reversible consequences
Class II
