The recent presidential executive order [1] aims to clarify the practice of developing guidance documents and their implementation. Current guidance documents, such as drug dissolution testing and bioequivalence, may be scrutinized as back-door law-making practices.
The law and regulations (such as cGMP) require that the recommended scientific methods be relevant, qualified, and validated for establishing and monitoring the quality of the drug products. However, FDA guidance documents ignore these requirements and enforce regulatory requirements by using irrelevant, non-qualified/non-validated testers and methods [2,3].