Modernizing FDA

The PDUFA agreements

Summary of the provisions of the letter of understanding between HHS Secretary Donna Shalala and Congress, which accompanies the PDUFA agreement, with timetables that are incorporated in the legislation passed by the House and Senate.

Agreement on protocols

Sponsors can submit specific questions to the agency, including elements of protocol design and scientific and regulatory requirements. Within 45 days of receipt of the protocol and specific questions, FDA will provide a written response that includes a succinct assessment of the protocol and answers to the questions posed by the sponsor.