The Office of Generic Drugs (OGD) has issued a revised Manual of Policies and Procedures (MaPP) updating the new organizational structure and defining where in the CDER and FDA organization reviews of bioequivalence studies with clinical endpoints will be conducted. The MaPP, 5210.4, Rev. 2, makes one thing clear, and that is that the initial review and final sign-off on a biostudy with clinical endpoints will now be conducted within the OGD’s Office of Bioequivalence, Division of Clinical Review (DCR). This is a departure from past practice where most all BE studies with clinical endpoints were consulted out to the new drug review divisions. While this change has taken place after the DCR was originally formed after GDUFA, this MaPP outlines the industry OGD’s procedures and review policy moving forward.
OGD will still seek assistance for biostatistician review, when needed, and will also avail itself of other CDER or FDA Offices or Centers when their input is required. However, the DCR’s residence in OGD will obviate the need for many consults, which should shorten the review period and decrease OGD’s reliance on the consult process, giving OGD more control over the reviews.
Just to remind you that a MaPP is a description of the how, when, and why an agency component does its job. It is a document intended for internal use, but is helpful to aid in industry’s understanding of FDA internal process. The full MaPP can be found here.
While most biostudies are conducted as pharmacokinetic, pharmacodynamic, or in vitro testing, there are times when a comparative clinical study is needed to establish bioequivalence. OGD shies away from such studies when other options are available because, according to the regulations, a biostudy with clinical endpoints is not as sensitive, accurate, or reproducible as other bioequivalence testing options.