Regulatory Report—DESI Program: FDA Continues Crackdown on Unapproved DESI Drugs

AGG Partner Alan G. Minsk, and Associates Jennifer S. Blakely and Diana Rusk Cohen, authored an article titled, “Regulatory Report—DESI Program: FDA Continues Crackdown on Unapproved DESI Drugs,” which was published in the February/March 2010 edition of Pharmaceutical Formulation and Quality magazine. The article describes how the Food and Drug Administration’s (FDA’s) recent enforcement actions demonstrate its goal to remove from the market products reviewed through the FDA’s Drug Efficacy Study Implementation (DESI) program for products the agency considers to be unapproved new drugs because they do not meet modern standards for safety, effectiveness, quality and labeling. The article highlights the reality that continued and significant noncompliance with current good manufacturing practices (cGMPs) may well result in warning letters or court action from the FDA. To read the full article, please click here.