FDA names acting director of OGD to director

SILVER SPRING, Md. — Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs. Uhl, a 30-year FDA veteran, had been serving as acting director of OGD since March 2013. 

 

In her time as acting director, Uhl has overseen OGD's implementation of the Generic Drug User Fee Act, which has had some success in decreasing application backlogs and increasing FDA inspections of foreign generic drug facilities, according to a report from the Regulatory Affairs Professional Society. 

 

"In Dr. Uhl’s capacity as acting director thus far, she has worked tirelessly to ensure the building of a strong foundation that will lead to timely access to safe and effective generic drugs," commented Ralph Neas, president and CEO of the Generic Pharmaceutical Association. "GPhA is hopeful that under Dr. Uhl’s leadership the FDA will continue to improve communications and transparency between the agency and generic drug manufacturers, particularly as we collaborate on the implementation of GDUFA, among other priorities," he said. "The Association looks forward to Dr. Uhl’s ambitious plans translating to meaningful action in 2015, particularly the establishing of target action dates for more than 3,500 filings."