JD Supra

eCTD Format Required for all Mutual Recognition Procedure Submissions

Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...
The National Law Review

FDA Permanently Exempts Type III DMFs for Drug Packaging Materials from eCTD Format Requirement

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
BioWorld

FDA: eCTD errors could lead to rejection

After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting ...
Business Wire

Akron Biotech Submits eCTD Drug Master Files with FDA for Its Suite of cGMP Immunotherapy Cytokines

BOCA RATON, Fla.--(BUSINESS WIRE)--Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and ...