4. United States Food and Drug Administration. FDA drug safety communication: new
restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk …

Employers, taxpayers, and patients are beginning to realize that the rising costs of
prescription drugs stem from higher-priced newer drugs that offer few proven advantages …

4. United States Food and Drug Administration. FDA drug safety communication: new
restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk …

Introduction Between 2010 and 2012, the US Food and Drug Administration and Health
Canada issued warnings to healthcare professionals emphasizing the increased risk of …

FDA officials are particularly concerned that traditional risk management strategies do not
appear sufficient to deal with current safety problems. At the CDER public hearing, agency …

Drug safety challenges have bedeviled the US Food and Drug Administration (FDA) for
many years, and for good reason. The phased approach to drug development is primarily …

Over the past 5 years, a series of recalls of high-profile prescription medications has
aroused serious concern about the safety of the nation's drug supply. Faced with a crisis of …

Adverse drug events (ADEs) occur in approximately 27% of outpatients, with approximately
1.5 million preventable ADEs occurring each year in the United States, mostly in the …

EFFORTS BY THEFOOD ANDDRUGADMINISTRATION (FDA) to ensure the safety of
prescription medicines histori-cally have focused on the requirements for therapies to gain …

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