Original Application submission

 

Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve‐outs based on patents and exclusivity claims

 

Labeling Query responses/ REMS and Patent Amendments/ PNP Requests

Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission of REMS correspondence/ Amendments Review of patent amendment & proprietary name review request Submission of Final Approval Requested

 

Life Cycle Management

Track RLD labeling changes Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA Submission of Labeling Supplements (CBE 0/ CBE 30/ PAS) Timely submission of REMS Review of revised artworks