ERG Presents Assessment of Federal Drug Review Program at Public Meeting

Valerie Overton recently presented findings from ERG's interim assessment of the first two years of the Food and Drug Administration's (FDA's) review program for innovative drugs at a public meeting at FDA Headquarters in Silver Spring, Maryland. Among other things, the program provides opportunities for drug sponsors to meet directly with regulators and obtain important feedback during the review process. ERG found that the program has been successful in enhancing review transparency and communication and also recommended some refinements. For the assessment, ERG analyzed extensive data about every drug application in the program and interviewed nearly every drug sponsor and FDA review team. ERG will continue to assess the program as FDA implements recommended refinements and then prepare a final assessment late next year, so stay tuned for more details!