May 04, 2006
FDA OKs Electronic Notification
The FDA has published final guidance that encourages the use of electronic media to communicate safety information about FDA-regulated products.
According to the FDA, they are "making clear in this guidance that manufacturers and others may disseminate communications by electronic means, including e-mail or other electronic methods."
The FDA notes that electronic notification is a permissible alternative to telegrams and first class letters as long as there are appropriate safeguards and mechanisms to ensure that the information can be accessed by the recipients. In addition to e-mail, manufacturers may use fax or text messaging to communicate safety information. The FDA guidance is available online.
Posted by rsk at May 4, 2006 05:26 PM