Pahala Simamora PhD U.S. FDA

Pahala Simamora PhD

Pahala Simamora PhD U.S. FDA Division Director, OPQ, CDER

Dr. Pahala Simamora is the Division Director for the Division of Liquid Based Products II in CDER/OPQ/OLDP at the FDA. Prior to joining the FDA in 2010, he spent 14 years in pharmaceutical industry with industrial experience in product development, process development, scale-up and validation. His division is responsible for collaborative evaluation and assessment of Abbreviated New Drug Applications (ANDAs) for topicals, injectables, ophthalmics, otics, nasal and inhalation drug products as well as oral liquid products and making risk-informed recommendations on their approvability.