The FDA published this guidance back in April but we have just now had the time to review it.

This guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) in complying with FDA’s new requirements for the submission of bioequivalence (BE) data.

FDA’s final rule on “Requirements for Submission of Bioequivalence Data” (the BE data rule) requires ANDA applicants to submit data from all BE studies the applicant conducts on a drug product formulation submitted for approval, including studies that do not demonstrate that the generic product meets the current bioequivalence criteria.

This guidance provides information on the following subjects:

• The types of ANDA submissions covered by the BE data rule
• A recommended format for summary reports of BE studies
• The types of formulations FDA considers to be the same drug product formulation for
• Different dosage forms based on differences in composition.

The important points of this guidance is that all studies must be submitted for ANDA applications and a format for those submissions is advised:

“For a suggested format for summary reports, please refer to the Office of Generic Drugs (OGD) Web page.6 The Division of Bioequivalence has developed model data summary tables in a concise format consistent with the ICH Common Technical Document (CTD). The tables, under the heading “Model Bioequivalence Data Summary Tables,” are available in Word and PDF formats. The FDA recommends that these table formats be used to organize the data for summary reports required by the BE data rule”

Drug Formulation

FDA amended the regulations to require an applicant to submit data from all BE studies conducted on the same formulation of the drug product submitted for approval.

“Same drug product formulation means the formulation of the drug product submitted for approval and any formulations that have minor differences in composition or method of manufacture from the formulation submitted for approval, but are similar enough to be relevant to the FDA’s determination of bioequivalence”

The guidance goes into greater detail on this point, this forms the bulk of the guidelines.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug  development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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