December 1995, Vol.
Drugs reach the market more quickly today than in the past.
Although the FDA has maintained its high standards for reviewing the safety and effectiveness of new products, recent efforts have been made to significantly decrease the time required for such reviews. Limitations of Pre-marketing Clinical Trials Short Duration Effects that have a long latency period or develop with chronic use are not detected in these trials. The indication for which the drug is being studied does not always include all uses for which the drug may ultimately be prescribed. June 199S, Center for Drug Evaluation and Research, FDA . Continued and close monitoring of newly marketed agents must be carried out through vigilant post-marketing surveillance performed by all health care professionals, thereby providing data to update prescribing information.