Late last year, the United States Food and Drug Administration (FDA) finalized a guidance entitled, “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.” The final guidance is largely the same to the draft guidance developed in 2017 as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) and outlines an enhanced pathway for discussions between the FDA and a prospective applicant preparing to submit an abbreviated new drug application (ANDA) for a complex product, or for applicants who have already submitted the same to the FDA. More specifically, the guidance covers information on requesting and conducting product development meetings, pre-submission meetings, and mid-review cycle meetings with the FDA.
As part of the commitments FDA made in connection with GDUFA II, FDA agreed to develop a program to assist ANDA applicants and prospective ANDA applicants of complex products before the submission of an ANDA to FDA. This pre-ANDA program is intended to clarify regulatory expectations for prospective applicants early in product development, assist applicants to develop more complete submissions, promote a more efficient and effective ANDA review process, and reduce the number of review cycles required to obtain ANDA approval, particularly for complex products.
A complex product, as defined in the GDUFA II Commitment Letter, is:
- a product with complex active ingredients (e.g., peptides, polymeric compounds, complex mixtures of [active pharmaceutical ingredients], naturally sourced ingredients); complex formulations (e.g., liposomes, colloids); complex routes of delivery (e.g., locally acting drugs such as dermatological products and complex ophthalmological products and dosage forms that are formulated as suspensions, emulsions, or gels); or complex dosage forms (e.g., transdermals, metered dose inhalers, extended-release injectables);
- a complex drug-device combination product (e.g., auto-injectors, metered dose inhalers); and
- any other product where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.
In the Federal Register’s announcement of the release of the final rule, the FDA said, “This guidance reflects a unified approach to all formal meetings between FDA and ANDA applicants or prospective ANDA applicants for complex products” and is intended to help ANDA applicants and prospective ANDA applicants generate and submit a meeting request and associated meeting package to the FDA.
As is typical with FDA guidance documents, this one does not establish any legally enforceable responsibilities, but instead describes the Agency’s current thinking and should be viewed only as recommendations, with the exception of specific cites to regulatory or statutory requirements.