Do FDA bioequivalence and drug dissolution testing guidance documents represent back door law-making?

The recent presidential executive order [1] aims to clarify the practice of developing guidance documents and their implementation. Current guidance documents such as for drug dissolution testing and bioequivalence may come under scrutiny as back door law-making practices.

The law and regulations (such as cGMP) require that the recommended scientific methods should be relevant, qualified and validated for establishing and monitoring 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].

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