Title:
Shook, Hardy & Bacon L.L.P. - Comment

Abstract:
...Shook, Hardy & Bacon L.L.P. (“SHB”) is pleased to submit comments in support of the above-referenced proposed rule. SHB agrees that the proposed rule clarifies FDA’s long-standing position regarding when changes may be made to prescription drug labeling under 21 C.F.R. § 314.70(c) (6)(iii), commonly known as the “changes being effected” regulation....