Important Update from the FDA: ANDA Action Letters Transitioning to Email Only

Important Update from the FDA: ANDA Action Letters Transitioning to Email Only

Starting this month, 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.

To help ensure timely receipt of action letters from FDA’s OGD, please ensure that your FDA Form 356h remains updated and lists a current, monitored, and secure email address. Applicants may apply for a secure email address with the FDA by contacting secureemail@fda.hhs.gov. For applicants who do not have a secure email address you will continue to receive paper copies of action letters.  

Benefits of using electronic correspondence instead of paper include :

• Faster Communication
• Less Expensive
• Better for the Environment

Questions and general information regarding the transition to electronic-only action letters can be directed to druginfo@fda.hhs.gov.