Question-Based Reviews - AAPS 2

The way in which FDA approves new drugs has been changing. Rolled out in February 2005, the FDA is in the process of going to "question-based" reviews, resulting in multiple questions from industry. Dr. Lawrence Yu, director for science in the office of generic drugs at the FDA, tried to explain the basis for these questions at the AAPS show in San Diego. "The regular CMC process was irrelevant," said Yu. "Don't forget we are scientists." The problems Yu listed were many. The reviews were specification and education specific. Little or no product or process development information was provided. The result was an "overly conservative" and often irrelevant specification. "These questions in the review process by FDA provide a roadmap. They help guide the reviewers and industry through the process," said Yu. The new reviews recognize the critical issues in the process. "Quality by Design assumes a well-controlled process. Now quality is ensured," said Yu. The FDA is now trying to understand both the product and process design. The "desired state" is based on science, risk, predictability and consistency. The emphasis on quality "eliminates the unnecessary fact finding of information." ANDAs under Quality by Review require an explanation of the product's development. The benefits of the new systems are brought about through the assumption of product quality. The result is an accelerated approach to approval and the reduced need for supplemental findings. "The goal is lower costs for all parties involved and higher quality products," said Yu. "What we are now trying to figure out in the review process is 'what is the specific drug product specification' and does it include all the critical drug attributes to ensure quality." BS