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FDA Goes Paperless

 

Target Health provides full Regulatory Affairs services for over 55 companies at FDA, including regulatory strategic planning, regulatory and medical writing, and eCTD publishing. Let us help you make this transition.

Small companies especially need to know that the deadline for the eCTD requirements for submissions to CDER and CBER is approaching for INDs and DMFs. The important dates established by FDA are summarized hereafter:

 

After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.

 

May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.

 

May 5, 2018Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

 

Construction in New York City

 

The view below is of 1 Vanderbilt Place across the street from Grand Central Station. The morning sun reflecting off the I-beams with a golden brilliance, gave rise to a certain urban exuberance!

The early morning sun lights up One Vanderbilt Place. © Jules Mitchel, Target Health Inc.

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

 

Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor

 

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