LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court
Finally, FDA’s Final Word on Unapproved Use Communications
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
FDA Furthers Efforts to Improve the Accelerated Approval Pathway through New Draft Guidance on Confirmatory Trials
New Accelerated Approval Guidance Underscores Need for Accountability
LDT Final Rule Series: Part 3 – Legal Challenges
FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software
LDT Final Rule Series: Part 2 – Response to the Rule
