CDER announces new guidance agenda for 2025
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.
This year, a new guidance is planned for release regarding considerations for container closure systems and device components for biosimilars and interchangeable biosimilars.
In the field of biostatistics, three new or revisedguidelines are planned for using Bayesian methods in clinical trials involving drugs and biologics, the application of informative Bayesian methods in pediatric clinical trials, and the implementation of master protocols for drug and biologics development.
In the clinical and medical fields, CDER plans to issue new guidance on the development of drugs to treat disseminated coccidioidomycosis. Additionally, the center plans to release a guideline addressing considerations for including older adults in clinical trials. The center also intends to publish a new enforcement policy regarding non-animal-derived thyroid products that are marketed without an approved biologics license application (BLA). Furthermore, CDER plans to provide guidance on the information needed to support the adequacy of safety evaluation planning.
Three new and revised guidance documents are planned for clinical pharmacology. These documents will cover clinical drug interaction studies involving combined oral contraceptives, the evaluation and study design of clinical pharmacogenomic studies, and guidelines for conducting pharmacokinetic studies in patients with impaired hepatic function.
CDER plans to issue new guidance on clinical pharmacogenomics information in drug and biological product labeling.
New guidelines are being developed for minor changes to solid oral dosage forms of certain OTC monograph drugs.
Three upcoming guidelines in the pharmaceutical quality and CMC (Chemistry, Manufacturing, and Controls) area are a new guideline on establishing impurity limits for antibiotics, a revised draft guidance on GMPs for medical gases, and a revised draft guidance on the certification process for designated medical gases.
The 2025 agenda is caveated by the fact that CDER is not obligated to follow this list and may issue guidance documents that are not included. Additionally, differing priorities from the Trump administration could influence the guidances that are ultimately published.
Guidance Agenda
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