Record year for generics will 'generate savings for Americans'

The timing of the release of statistics showing that 2016 was a record year for the US Food and Drug Administration’s (FDA) generic drug program “couldn’t be better amid concerns about rising drug prices,” according to a senior figure at the agency.

Kathleen Uhl is the FDA’s director for the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, which last year generated the highest number of approvals in the history of the program. The figure of more than 800 includes both full and tentative approvals and surpasses 2015’s previous record of 726.

"The FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals"