Performance Improvement 2001. The FDA Regulatory Methods Validation Program for New and Abbreviated New Drug Applications


This report published in Pharmaceutical Technology in January 2000. The article describes the Food and Drug Administration methods validation program for proposed regulatory methods submitted through the new abbreviated new drug application processes. The program is conducted by the Center for Drug Evaluation and Research (CDER) to ensure that scientifically well-founded regulatory methods are available to assess the quality of CDER-approved products. Industry, FDA, and the United States Pharmacopeia and the National Formulary have the common objective of ensuring that drugs in the US marketplace have consistent standards for drug substances and drug product regardless of the synthesis and manufacturing process. This is achieved by ensuring that the analytical methods used for new drug products are submitted for adoption as public standards soon after approval for marketing.

AGENCY SPONSOR: Center for Drug Evaluation and Research

FEDERAL CONTACT: Moheb Nagr, 314-589-2136

PIC ID: 7106

PERFORMER: Food and Drug Administration, St. Louis, MO