ORA continued to spend user fee dollars despite its inability to travel for facility inspections, while CBER found little generic and biosimilar work during FY 2020.
Some centers within the US Food and Drug Administration saw user fee spending decline compared to estimates during fiscal year 2020, in part because of the pandemic, although not in what some may consider a predictable pattern.
The Center for Biologics Evaluation and Research, which became the center of attention amid COVID-19 vaccine development, conducted very little user fee-supported work for the FDA’s biosimilar and generic drug...
The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals.
The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.
The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.
