Home » Proposed Rule Would Prevent Petitions From Blocking ANDAs, 505(b)(2) Applications
Proposed Rule Would Prevent Petitions From Blocking ANDAs, 505(b)(2) Applications
Under a new proposed rule, FDA decisions on ANDAs or 505(b)(2) applications would not be delayed by pending citizen petitions, or petitions for stay of action, unless a delay is necessary to protect public health.
Drug Industry Daily
Drug Industry Daily
Upcoming Events
-
23Apr
-
25Apr
-
07May
-
14May
-
30May