Improving the Quality of Abbreviated New Drug Application Submissions to the Food and Drug Administration; Establishment of a Public Docket

Streszczenie

The Food and Drug Administration (FDA) is establishing a public docket to receive input and suggestions from the public on ways to improve the quality of abbreviated new drug applications (ANDAs) and associated amendments and supplements to FDA's Office of Generic Drugs (OGD). Specifically, FDA is interested in hearing about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help address, for example by providing more or better information to industry. This action is intended to solicit suggestions that will improve the completeness and quality of ANDA submissions to FDA. FDA is also seeking input on how to best share suggestions for improving the quality of ANDAs with the generic drug industry. More complete, higher quality ANDA submissions will positively affect the availability of low-cost, high-quality generic drugs to the public.