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FDA Modernization Act of 1997

Known as: FDAMA 
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2010
2010
Compounding Problems and Compounding Confusion: Federal Regulation of Compounded Drug Products and the FDAMA Circuit Split
Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to… 
Review
2007
Review
2007
Deadline Effects in Regulatory Drug Review: A Methodological and Empirical Analysis
This paper elaborates two sets of statistical models for the analysis of regulatory review deadlines or “review time goals” and… 
Review
2005
Review
2005
False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products
This article details pharmaceutical company liability for off-label promotional marketing strategies. Despite near record… 
2002
2002
Exploring the frontiers of law and science: FDAMA's pediatric studies incentive.
Review
2002
Review
2002
Essentials of Pharmacy Law
INTRODUCTION TO PHARMACY LAW The Evolution of Pharmacy Practice Introduction Meeting the Challenge The Expanded Role Pharmacy's… 
2001
2001
FDAMA's written request list: medicines for children
Review
2001
Review
2001
The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines
The Prescription Drug User Fee Act of 1992 and the Food and Drug Administration Modernization Act of 1997 include provisions that… 
2001
2001
FDA's implementation of FDAMA: an interim balance sheet.
2001
2001
FDA's implementation of FDAMA: an interim balance sheet.
2000
2000
Clinical Trial Design and Alterations in Drug Disposition with Age
Most drugs lack information on their safe and effective use in children. This dilemma limits the number of potentially useful… 
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