The changes apply to applications submitted three years after enactment
What the document says“The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), that is submitted on or after the date that is 3 years after the date of enactment of this Act.”
Subsection (c) of section 6601 makes the amendments apply to applications under section 505(b) of the Federal Food, Drug, and Cosmetic Act and section 351(a) of the Public Health Service Act submitted on or after three years from enactment.
What the document actually says“The amendments made by this section apply with respect to any application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and any application under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)), that is submitted on or after the date that is 3 years after the date of enactment of this Act.”
The changes cover an application sent in later. It must come in three years after the day this law passed, or after that.
Drug work takes years to plan. A rule that hit at once would catch studies already under way. The delay gives makers time.
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