Day: January 19, 2017

Starting 5 May 2017, FDA will require all DMFs be submitted only in the electronic CTD format creating a huge burden on owners of non-critical DMFs. Converting to eCTD format requires special skills, software and resources, the cost of which could be prohibitive to small manufacturers. To avoid the hassle of converting to eCTD format, … Read more

A GAO report on FDA’s foreign inspections paints a very dire picture for the current status of inspections. There are about 5000 manufacturing sites registered with FDA of which 3000 are located outside of the US; about 1000 of these foreign sites have never seen an FDA audit. With about 40% of finished products and … Read more