Nov 4, 20196 minAnnual Registration Renewals: Ensuring Compliance to Avoid InactivationEvery year, from October 1st to December 31st , sponsors are required to renew their Establishment Registrations with FDA, as well as...
Oct 24, 20193 minDrug Master Files: Highlights of the Updated FDA GuidanceOn October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
Oct 3, 20192 minNew Draft FDA Guidance: Electronic Format for Medical Device SubmissionsOn September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...
Sep 6, 20194 minFDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval ProductsBackground on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...