Pre-ANDA meetings and FDA's advice program for complex generics

In fiscal 2025, companies developing generic versions of hard-to-copy drugs asked FDA for 97 product development meetings. FDA granted 81, denied 11 and held 63, according to the agency's GDUFA performance report to Congress². Requests for the next step, a pre-submission meeting held months before an application is filed, numbered seven. FDA granted two.

Those meetings make up the pre-ANDA program, FDA's formal channel for advising developers of complex generics before they submit an abbreviated new drug application. The stakes are measurable. Complex products fail review more often than other generics, and every failed cycle adds months to the path to approval, as our piece on ANDA review goal dates shows.

Where the program came from

FDA first described formal meetings for complex generics in a draft guidance announced in the Federal Register on Oct. 3, 2017⁵, as part of the second round of generic drug user fees. The agency revised the guidance in November 2020 and again in October 2022 to match the third round, known as GDUFA III, according to the current guidance page³.

FDA's GDUFA III commitment letter¹ states the program's aim plainly. Its goal is "to clarify regulatory expectations for prospective applicants early in product development, assist applicants in developing more complete submissions, promote a more efficient and effective ANDA assessment process, and reduce the number of assessment cycles required to obtain ANDA approval."

Which products count as complex

Most meeting types are reserved for complex products. FDA's 2022 meetings guidance⁴, quoting the commitment letter, says complex products generally include:

• Products with complex active ingredients (peptides, polymeric compounds, complex mixtures, naturally sourced ingredients), complex formulations (liposomes, colloids), complex routes of delivery (locally acting drugs such as dermatological products, complex eye products, and ear products formulated as suspensions, emulsions or gels) or complex dosage forms (transdermal systems, metered dose inhalers, extended-release injectables)
• Complex drug-device combinations, such as pre-filled auto-injectors and metered dose inhalers
• Other products where uncertainty about the approval pathway or an alternative approach "would benefit from early scientific engagement"

Our explainer on complex generics covers why so many of these products still have few or no copies.

The meeting types and their clocks

Each meeting comes with a GDUFA III performance goal, measured in calendar days.

Sources are the commitment letter and FDA's meetings guidance. Controlled correspondence, governed by a separate guidance finalized in March 2024⁶, is open to all generic developers, and FDA treats it as the first stop. The agency grants a product development meeting only when, among other conditions, the developer submits a complete meeting package and "a Controlled Correspondence response would not adequately address" its questions. FDA can meet the goal by sending a written response instead of holding a meeting.

A pre-submission meeting is narrower than its name suggests. The guidance says it gives a developer a chance to present "unique or novel data or information" planned for the application, such as formulation or key studies. FDA does not substantively assess data there, and the meeting "is not an opportunity to determine whether the application is acceptable for receipt."

How much the program is used

Fiscal 2023 to 2025 meeting figures are from Table 22 of the fiscal 2025 performance report². Fiscal 2026 figures are from the FDA-TRACK dataset⁸, which counts submissions by month and does not report grants. For comparison, approval counts by year are on our approvals page.

Written questions far outnumber meetings. FDA received 3,916 controlled correspondence submissions in fiscal 2025, its monthly activity report⁷ shows, and 3,509 from October 2025 through August 2026. Complex-product ANDAs, the applications these meetings are meant to prepare, numbered 100 and 139 over the same periods.

Two patterns stand out. Product development meetings are steady at roughly 85 to 100 requests a year, with denials falling from 28 in fiscal 2023 to 11 in fiscal 2025. Pre-submission meetings are rarely granted. In three years, FDA received 19 requests and granted two. Meetings tied to product-specific guidances drew no requests at all in fiscal 2023 through 2025, though PSG teleconferences drew a handful.

In preliminary results, FDA reported meeting every fiscal 2025 performance goal for the pre-ANDA program. It decided 92 of 97 product development meeting requests within 14 days, for example.

The problem the meetings target

Complex products are where review cycles pile up. An April 2025 analysis by the Office of Generic Drugs⁹ found that complex products made up about 14 percent of ANDAs submitted in fiscal 2018 and 17 percent in fiscal 2022. About 25 percent of those complex applications were approved by the second review cycle, compared with roughly 38 to 40 percent of all applications. Complex products accounted for about 40 percent of major bioequivalence deficiencies in first-cycle rejection letters for the fiscal 2018 group, well above their share of submissions.

That analysis listed product development meetings, controlled correspondence and mid-cycle and post-CRL meetings among the tools meant to resolve problems "before they become deficiencies." Our guides to how a generic drug gets approved and bioequivalence testing cover the standards those deficiencies measure against.

What changes in 2026 and after

A new law already applies to these meetings. The Consolidated Appropriations Act enacted Feb. 3, 2026, requires FDA to identify the specific inactive ingredient behind a failed formulation-sameness check and quantify the deviation, for products that must match the brand's formulation. An Office of Generic Drugs presentation in April 2026¹⁰ said the requirement covers "all controlled correspondence, pre-ANDA meetings, ANDAs, and post-approval supplements" pending on or submitted after that date.

A larger overhaul is in the next user fee deal. FDA's proposed GDUFA IV commitment letter¹¹ for fiscal 2028 through 2032 would replace the current meeting names with four types defined by their deadlines: TYPE 30, TYPE 60, TYPE 90 and TYPE 120 meetings. Pre-submission meetings for complex products would become TYPE 60 meetings. A new Complex Generic Initial Advisory meeting would let developers test the feasibility of a strategy "before an applicant or prospective applicant begins significant development work" when no FDA guidance exists. FDA scheduled a public meeting on the proposal for Sept. 17, 2026, and GDUFA III authority expires in September 2027, according to its GDUFA IV page¹². User fees and the rest of the program are covered in our GDUFA explainer.