• Director's Corner With Dr. Janet Woodcock:  Looking back on 2016 accomplishments and Moving Forward in 2017.

• Manual of Policies and Procedures (MAPP) 4200.3 Rev.1 Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health (PDF -112KB)

• Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry  (PDF - 115KB)

Update to Guidance

Section I. Introduction

• Paragraph added describing rationale for changing timetable for required master file submissions in eCTD from 24 months to 36 months.

Section III.B. Timetable for Implementation of Electronic Submission Requirements

·         Updated to reflect that the requirement for master files to be filed electronically takes place 36 months after May 5, 2015.