Taming the Regulatory Beast: Role of Regulatory Trend Analysis in Successful FDA Approval

The biggest risk in drug development is failure to convince the FDA that your product meets the requirements for marketing approval. By the time a company files a New Drug Application (NDA), it believes that sufficient evidence is available in support of the marketing approval, based on its understanding of the regulations and requirements. However, about 40 percent of the NDAs submitted to the FDA are rejected for one or another reason while more than half go through multiple cycles of review adding additional cost and delays to the ultimate approval to market a product. A recent independent survey of FDA review process found that most rejections or delays are due to one or two issues that, in the opinion of the FDA reviewers, could have been easily resolved with appropriate review of past information and consultation with the FDA.

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Avoiding the CAPA Calamity

Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.

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