With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows:

  • Administrative/Procedural – 8
  • Artificial Intelligence – 1
  • Biosimilars – 6
  • Biostatistics/Clinical/Medical – 2
  • Clinical/Medical – 9
  • Clinical Pharmacology – 5
  • Compounding – 8
  • Drug Safety – 2
  • Electronic Submissions – 1
  • Generics – 24
  • ICH – 3
  • Labeling – 3
  • Pharmaceutical Quality CGMP – 3
  • Pharmaceutical Quality/CMC – 10

The generics category leads this year’s list by a wide margin with 24 proposed new or revised guidance documents. Generic guidances will have a significant emphasis on ANDA applications, filing requirements, in vivo and in vitro bioequivalence issues, refuse-to-receive of DMFs and Q&As, as well as a revised draft on the retention of bioequivalence samples.

The guidance plan also has considerable emphasis on the compounding space. This is as FDA tries to get a better handle and control over 503A and 503B compounders regarding the how, what, when and where of compounding to ensure that compounders are following the statutory and regulatory requirements and not acting as manufacturing facilities. FDA has identified issues involving the improper use of certain APIs, whether a compounded product duplicates an FDA-approved product, and whether a legitimate medical need exists for a deviation from the approved product for an individual patient, as well as the safety and effectiveness of compounded products. We expect to see some clarification and perhaps limits of some of compounders’ activities imposed by the guidances in this arena.

In the clinical/medical group of guidances, the FDA will address (among other things) race and ethnicity in a revised draft, consideration for inclusion of older adults in clinical studies and also a guidance on the development of animal-derived thyroid products which will address FDA thinking on what turned out to be a rather controversial issue during the past couple of years concerning the long-time marketed “grandfathered” (yet still unapproved) desiccated thyroid product.

In summary, this list provides a brief overview of selected soon to be issued guidance documents across several categories. Please review the list for any proposed guidances that could potentially impact your firm’s current or future drug development plans and monitor the publication of these guidance documents to ensure that your development strategy remains aligned with FDA expectations. Now that the Agency’s planned guidance documents have been publicly released, sponsors whose development timelines may precede the issuance of a relevant guidance should consider meeting with the appropriate CDER office before making key development decisions. Doing so can help ensure that development plans remain aligned with FDA expectations.