Regulatory review intervals for ophthalmic new drug applications at the US Food and Drug Administration.

@article{Novack1998RegulatoryRI,
  title={Regulatory review intervals for ophthalmic new drug applications at the US Food and Drug Administration.},
  author={Gary D. Novack},
  journal={American journal of ophthalmology},
  year={1998},
  volume={126 1},
  pages={122-6}
}
PURPOSE To evaluate the regulatory review interval for recent ophthalmic new drug applications (NDAs) at the U.S. Food and Drug Administration (FDA). METHODS Based on publicly available information regarding submission and approval dates, the timing of FDA review of NDAs of first indications for therapeutic ophthalmic drugs in the 1990s was evaluated. RESULTS The mean (median) interval of the 19 NDAs from submission to approval decreased from 44 (18) months in 1990 to 11 (10.6) months in… CONTINUE READING