The House passes FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.
Stakeholders at FDA's public hearing on the Commissioner’s National Priority Voucher program urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation.
The House passes FDA’s appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.
Stakeholders at FDA's public hearing on the Commissioner’s National Priority Voucher program urge the agency to temporarily suspend the initiative and establish a more transparent framework governing its operation.
FDA releases a draft guidance outlining post-approval responsibilities facing manufacturers of generic drugs, highlighting requirements ranging from adverse event reporting and drug shortage notifications to labeling updates, promotional material submissions and compliance with Risk Evaluation and Mitigation Strategies.
FDA issues Xspray Pharma a complete response letter for the company's NDA for Nilopki, an improved formulation of nilotinib designed to compete with Novartis' chronic myeloid leukemia therapy Tasigna.
