As the FDA has recently been implementing mandates toward more electronic submissions, HealthLawPolicyMatters.com listed some of the recent actions by the Agency to expand electronic submissions for anyone who submits applications and materials to the FDA.
Here are four things to know about electronic submissions and the FDA, according to the article:
1. All device manufacturers and importers must submit their MDRs electronically through the Electronic Submissions Gateway, effective August 14, 2015.
2. Postmarketing adverse event reports for drugs and biologics must be submitted electronically, through the ESG or through the Safety Reporting Portal, effective June 10, 2015.
3. New drug applications, abbreviated new drug applications and covered biologics license applications must be submitted electronically to the FDA as of May 15, 2017. Sponsors must also use the current electronic version of the Common Technical Document.
4. Prescription drugs by manufacturers, packers, and distributors will also need to be electronically submitted 24 months after this recent draft guidance is finalized.