(Saint Petersburg, FL - August 11, 2011)

A report recently released by the FDA from its Center for Drug Evaluation and Research (CDER) identified regulatory needs that will lead strategic planning for FDA in the next several years.

According to Jonathan Lewis, Principal at Advanced Biomedical Consulting, a leading FDA compliance consulting firm, the report details several current needs and subsequent foci, of which the following four are of most importance to pharmaceutical manufacturers:

• Improving risk assessment and management strategies, associated with both drugs that have not gone through the FDA approval process and those that have

• Determining the accuracy of postmarket data in safety analyses

• Determining whether current methods of information distribution are effective in conveying important medical information, and whether those methods have an impact on patient and health care provider behavior and outcomes

• Obtaining a better understanding of how the variability in drug components and manufacturing processes affects product quality and performance

CDER plans to work with industry, education, and nonprofit groups to further explore the ideas outlined in the report.

 (Saint Petersburg, FL - August 11, 2011)