US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Peter Bach warns against Medicare ceding its scientific authority to FDA and automatically covering all drugs and devices the agency clears, suggesting the Alzheimer’s drug be subject to a CMS Innovation Center trial if FDA-approved. Others say the drug could highlight flaws in Medicare Part B’s payment system.

From EMBARK data to labeling materials, the potential reasons for the three-month user fee delay are as varied as the ups and downs of the Biogen/Eisai Alzheimer’s candidate’s development saga.