The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance documents scheduled for release this year. Many of the new and revised guidelines slated for release are for generic drugs, and many also address new International Council for Harmonization (ICH) topics.
 
Of the 88 guidelines scheduled for release this year, 28 are new, while many others are carried over from the July 2024 agenda.
 
Many of the new and revised guidelines are aimed at the generic drug industry.  Among these are a new guidance on Abbreviated New Drug Applications (ANDAs) for certain highly purified systemic peptide drugs, the content and format of ANDA submissions, and bioavailability and bioequivalence studies for nasal products.
 
Also included are new guidelines regarding post-approval requirements and resources for ANDAs, considerations for design differences in comparative analyses for drug-device combination products, new product-specific guidance, and the use of Type V Drug Master Files for model master file submissions.
 
Many of the new and revised guidelines also focus on International Council for Harmonisation (ICH) topics. These include new ICH E21 guidance on including pregnant and breastfeeding individuals in clinical trials; E22, which covers general considerations for patient preference studies; ICH M4Q(R2), which addresses common technical document (CTD) quality-related questions; ICH M11, on clinical electronic structured harmonized protocols (CeSHaP); ICH M13C, regarding bioequivalence for immediate-release solid oral dosage forms; and ICH Q3C(R10), which maintains the guidelines on residual solvents....[FDA]