USA – FDA’s OCP 2020 report highlights achievements post-reorganization

The US Food and Drug Administration’s (FDA’s) Office of Clinical Pharmacology has issued its 2020 report, highlighting the office’s contributions to drug development, research, policy and communication.

Describing the COVID-19 pandemic as the “personal and professional challenge of a lifetime,” Issam Zineh, PharmD, MPH, Director of the Office of Clinical Pharmacology (OCP), said OCP staff met the moment during a global public health crisis by creating “strike teams to address scientific and regulatory issues related to the pandemic.

“Internally, we established multiple, new methods to communicate the latest research, ensuring that our staffers had the necessary data and tools to make the most informed regulatory decisions,” Zineh wrote in a director’s address preceding the annual report.

OCP, which is itself an office within the FDA Center for Drug Evaluation and Research (CDER) Office of Translational Sciences, was recently part of a larger reorganization effort in CDER to modernize the New Drugs Regulatory Program. That reorganization, now complete, also saw OCP expand to 8 review divisions, adding a new Lifecycle Management program and Strategic Communications Team. “Our continued efforts at organizational excellence ensure better review quality and process efficiency, with a vision towards serving patients by delivering safe, effective, and high-quality drugs,” the authors of the report stated…