According to an article in the Pink Sheet (here, subscription required) authored by Sarah Karlin-Smith, some policy staff are returning to work at the Center for Drug Evaluation and Research. Hopefully that means that we will see more timely work on product-specific guidances (PSGs), informational postings, and statistical reporting from the Agency. In the Office of Generic Drugs (OGD), there has been no update to the Generic Drugs Program Monthly and Quarterly Activities Report since the February numbers were published. That’s an entire quarter of the year with no data from the FDA, contrary to the transparency promised in the GDUFA commitment letter.
The Pink Sheet article also indicates that some of the employees subject to the reduction in force (RIF) are confused about what is going on with regard to their status. Fortunately, it appears that someone in the government recognizes that more mistakes have been made in the decisions behind who, specifically, was subject to the RIFs and, as a result, is slowly bringing back some staff who have critical impacts on the drug review programs, including some of the User Fee staff who were let go and were about to participate in the upcoming negotiations for the various UFAs.
Hopefully, we will see some more stabilization in the promised reporting, general guidance documents, PSGs for bioequivalence, and other posting on webpages that had been discontinued. For example, the What’s New Related to Drugs page (here), which provided very useful information to the industry and public, has not had any updates since March 28, 2025.
