Study concept and design: Sacks, Yasinskaya, Lanthier, Sherman.
Acquisition of data: Sacks, Shamsuddin, Yasinskaya, Lanthier.
Analysis and interpretation of data: Sacks, Shamsuddin, Bouri, Lanthier.
Drafting of the manuscript: Sacks, Shamsuddin, Yasinskaya, Sherman.
Critical revision of the manuscript for important intellectual content: Sacks, Shamsuddin, Bouri, Lanthier.
Statistical analysis: Sacks.
Administrative, technical, or material support: Shamsuddin, Bouri, Lanthier.
Study supervision: Sacks, Sherman.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the views of the FDA.
Additional Contributions: We are grateful to Ann Staten, RD, for compiling the list of new molecular entities and collecting the action letters and other related documents; and to Arlene Conway, Nancy Derr, MA, and Mark Geanacopoulos, PhD, for their editorial advice. All are employed by FDA and have not received compensation for this work.