Acceptable and Complete?

An application must contain sufficient information to allow a review to be conducted in an efficient and timely manner. Upon receipt of the application a pre-filing assessment of its completeness and acceptability is performed by a project manager within the Regulatory Support Branch, Office of Generic Drugs. If this initial review documents that the application contains all the necessary components, an "acknowledgment letter" is sent to the applicant indicating its acceptability for review and confirming its filing date.

Once the application has been determined to be acceptable for filing the Bioequivalence, Chemistry/Microbiology and Labeling reviews may begin.