Perrigo has appointed Keith Webber head of regulatory review, effective Oct. 21. This new role will have responsibility for advancing the approval of all of Perrigo's Consumer Healthcare (CHC) and Prescription Pharmaceutical (Rx) regulatory applications pending with the FDA, providing guidance on scientific and regulatory strategy for new CHC and Rx pipeline products under development and continuously advancing the quality of new regulatory applications.
Previously, Keith was acting director of the office of the FDA's pharmaceutical science in the Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. He also has been director of Office of Generic Drug (OGD), where he directed FDA regulation of generic pharmaceuticals including, legal, chemistry, bioequivalence, microbiology, clinical and labeling. He was in several leadership roles within the FDA responsible for regulating pharmaceutical quality, biopharmaceutical drug development and monoclonal antibody-related biopharmaceuticals research and review.