Electronic Adverse Event Reports Mandatory Under Proposed Rule

The FDA has proposed a rule requiring that drug and biologic manufacturers submit all reports of adverse events electronically, making formal an option that has been on the books since 2000. The proposed rule will save time and costs, Gerald Dal Pan, director of CDER’s Office of Surveillance and Epidemiology, said in a recent conference call with reporters. The rule was published in the Federal Register last week and comments are due Nov. 19.
Washington Drug Letter