DRUG DISCOVERY DEVELOPMENT (DDD): Drug safety is still monitored

Sponsors must submit reports of adverse events
periodically

Newly approved drugs- filed quarterly for the first 3
years, then annually

AE considered as serious and unexpected- sponsor
provides written report to FDA within 15 days of
receipt of info

Question

Drug safety is still monitored

Sponsors must submit reports of adverse events
periodically

Newly approved drugs- filed quarterly for the first 3
years, then annually

AE considered as serious and unexpected- sponsor
provides written report to FDA within 15 days of
receipt of info

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Safety monitoring

Drug safety is still monitored Sponsors must submit reports of adverse events periodically Newly approved drugs- filed quarterly for the first 3 years, then annually AE considered as serious and unexpected- sponsor provides written report to FDA within 15 days of receipt of info