13 citations
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May 2006 in “Annals of Saudi Medicine” The researchers reported substantial discrepancies in prescribing information between generic drugs marketed in Saudi Arabia and standard references, indicating a need for regulatory improvements to ensure accuracy and patient safety.
1 citations
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January 2013 in “Scholar Commons (University of South Carolina)” This article discusses the regulatory gap in updating labeling responsibilities for generic drugs and argues for the FDA to use negotiated rulemaking to develop more effective drug regulations, but provides no new empirical results.
October 2008 in “Journal of Intellectual Property Law & Practice” The article concludes that recent legal rulings have strengthened the protection of pharmaceutical patents against generic competition.
1 citations
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January 2010 in “Elsevier eBooks” Any drug can cause skin reactions, but antibiotics, NSAIDs, and psychotropic drugs are more common, with some reactions being life-threatening.
188 citations
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October 2012 in “The AAPS Journal” This review discusses strategies for developing semi-solid topical generic products to match the quality of reference-listed drugs, using concepts like quality by design and reverse-engineering, but reports no new results.