FDA & CRCG Host December 2026 LAI Generics Workshop On ANDA Gaps

ANDA sponsors developing long-acting injectable generics will have a direct line to FDA regulatory expectations on December 1–2, 2026, when the agency co-hosts a two-day hybrid workshop with the Center for Research on Complex Generics (CRCG) in Rockville, Maryland, an event structured around the deficiency patterns that have consistently stalled complex injectable submissions.

The agenda targets the technical fault lines most frequently cited in LAI ANDA reviews: formulation and excipient characterization, in vitro release testing (IVRT) method development, bioequivalence approaches for extended-release dosage forms, and the application of model-integrated evidence frameworks. Dosage form coverage spans drug substance suspensions, polymeric microspheres, implants, and in situ forming depots, a range that reflects the breadth of the current LAI generic pipeline.

For QA and regulatory leads, the in-person track carries additional weight. Two sessions are reserved exclusively for on-site attendees: an open-format dialogue with FDA, academic, and industry subject matter experts, and a small-group case study session using consensus mapping to work through unresolved challenges in IVRT method development, bioequivalence design, and model-integrated evidence strategies. These formats are designed to surface actionable outcomes, not position papers.

Virtual attendees retain access to all presentations, panel discussions, and real-time Q&A submission, along with free post-event recordings of the open sessions. Registration is free for both attendance modes. The event is held at The Universities at Shady Grove, Building II, 9630 Gudelsky Drive, Rockville, MD 20850.

Read against the current GDUFA III reauthorization cycle and the agency's expanding product-specific guidance library for complex generics, the workshop positions itself as a pre-submission alignment opportunity for sponsors whose LAI programs are approaching the ANDA filing stage.

The small-group case study session on Day 2 represents a measurable checkpoint: sponsors that engage directly with FDA scientists on IVRT methodology and PK study design will be better positioned to anticipate deficiency letters before submission.

Source: FDA What's New: Drugs RSS Feed via fda.gov, September 29, 2026. Workshop dates: December 1–2, 2026, 8:00 a.m.–5:45 p.m. ET (Day 1) and 8:00 a.m.–4:00 p.m. ET (Day 2).