The US FDA requires facilities that are engaged in manufacturing, processing, packaging, or storing food pharmaceuticals and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facilities and list the products. Companies must annually renew the registration and listings. FDA US agent is required … Continue reading How To Register With The FDA
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 … Continue reading Your FDA US Agent has established FDA secure email address ?