Two senior FDA officials, Curtis Rosebraugh and Donna Griebel, stepped down from positions at the agency's Center for Drug Evaluation and Research (CDER) on Friday, an FDA spokesperson told BioCentury.
The spokesperson said both exits are retirements.
Rosebraugh was director of the Office of Drug Evaluation II, which covers medicines for addiction, allergy, analgesia, anesthesia, diabetes, endocrine, metabolism, pulmonary and rheumatological conditions. Mary Thanh Hai, who had been deputy director, will be acting director while FDA seeks a permanent replacement for Rosebraugh.
Griebel was director of the Division of Gastroenterology and Inborn Errors Products (DGIEP), which regulates INDs, NDAs and BLAs for drugs and biologics in gastrointestinal and inborn metabolic conditions. The division's deputy director, Dragos Roman, will become acting director.
Last week, Badrul Chowdhury, director of CDER's Division of Pulmonary, Allergy and Rheumatology Products, left the agency to become an SVP at AstraZeneca plc (LSE:AZN; NYSE:AZN).