Responding To Cybersecurity Threats: FDA Addresses Postmarket Questions In Draft Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA issued a draft guidance on how companies should monitor and respond to potential cybersecurity threats in the postmarket setting. Some cybersecurity problems will require a recall action, but in most cases urgent notification to FDA will not be necessary, the document suggests.
You may also be interested in...
FDA Says It Is Changing Its Cybersecurity Culture, And Others Should Too
Speaking at the 2015 mHealth Summit, Suzanne Schwartz, the FDA device center's top cybersecurity expert, said the agency is undergoing a cultural shift to better deal with device cybersecurity vulnerabilities and urged manufacturers, security researchers and hospitals to do the same.
FDA Proposal For Cybersecurity Info In Pre-market Submissions Generates Debate
Medical device firms and internet security groups disagree over whether an FDA guidance should recommend that companies document their cybersecurity measures in pre-market submissions.
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.