To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

I

119TH CONGRESS

1ST SESSION

H. R. 1051

To amend the Federal Food, Drug, and Cosmetic Act to allow for the

approval of an abbreviated new drug application submitted by a subse-

quent applicant in the case of a failure by a first applicant to commence

commercial marketing within a certain period, and for other purposes.