Regulatory Actions
Studies conducted at University of Pittsburgh on regulatory actions recently published
Published in Medical Letter on the CDC and FDA, August 31st, 2008
"A process is described for formulary revisions consistent with the Food and Drug Administration (FDA)'s current initiative to ensure that all drugs marketed in the United States have been approved for safety and efficacy. A list of pre-1938 drugs (i.e., formulations marketed before the Federal Food, Drug, and Cosmetic Act established safety requirements) was compiled from USP DI Volume III and international Journal of Pharmaceutical Compounding lists," scientists in the United States report.
"Products on the resulting list were reviewed for current marketing and FDA approval status and for availability. The project team recommended formulary addition or retention if a...
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