Mr. Pallone (for himself and Mr. Guthrie) introduced the following bill; which was referred to the Committee on Energy and Commerce
Introduced in House (IH)
To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act to extend the period for a first applicant, with respect to a generic drug, to obtain tentative approval without forfeiting the 180-day exclusivity period, and for other purposes.
Frank Pallone Jr.
Committee on Energy and Commerce (Standing)
United States Code References
21 U.S.C. 355
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