Companies frequently struggle with interpreting the advice provided in FDA’s Guidance Documents. A favorable but incorrect interpretation could cause delays, disruptions and disrepute with the FDA reviewers while a more conservative reading could leads to overkill and waste of resources. FDA has released more than 4000 Guidance Documents on practically all areas of compliance and plans to release about 100 new such documents every year in the near future. As the number of these advisory documents increase, the uncertainty about how best to use them in a given situation also increases. Although the guidance document hold a prominent disclaimer that the information contained is not binding on either the FDA or the companies, these documents are practically the law. They describe the current thinking of the Agency and no discussion with the FDA is complete without referring to one or more guidance docs. Most guidance documents try to cover broad perspectives regarding all possible scenarios regarding a given issue. FDA expects that the affected companies will review, interpret, analyze and customize the provided information to their specific situation. Easier said than done.
