EA of Investigational Drugs: CDER experience over a 10-year period

Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period. Therapeutic Innovation & Regulatory Science, 50(6), 705–709.

Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety. Therapeutic Innovation & Regulatory Science, 51(2), 246–249.