FDA Seeks Feedback on Best Practices for Postmarket Surveillance

The FDA invited comments on a draft guidance that outlines what the agency considers best practices for postmarket safety surveillance for drugs and biologics.

The 38-page draft details the sources the agency uses to identify postmarket safety issues, including REMS assessments, citizen petitions, media inquiries, and periodic safety reports manufacturers must file with the agency, among others.

“We are constantly seeking new methods for improving our surveillance practices, and we invite the public to comment,” said CDER Director Janet Woodcock.