Your FDA US Agent has established FDA secure email address ?
FDA secure email address is mandatory requirement for receiving regulatory communications through CDER.
Starting from October , abbreviated new drug application (ANDA) applicants with secure email accounts will begin receiving action letters (approvals, tentative approvals, complete responses) by secure electronic communication only as the U.S. Food and Drug Administration (FDA), including its Office of Generic Drugs (OGD), continues to move away from paper communications.
Make sure your 356h includes secure email address, so that you can receive electronic communication from FDA related to your ANDA.
FDAbasics offers US Agent services for ANDA applicants and facilitate efficient communication process between ANDA applicant and FDA. BACK