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…
