Audrey Mercer

What To Watch: Potential Increase In Enforcement Of "RUO" Diagnostics

LDT Final Rule Series: Part 4 – Rule Overturned By Federal District Court

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FDA Furthers Efforts To Improve The Accelerated Approval Pathway Through New Draft Guidance On Confirmatory Trials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

The Future Of FDA Policy: Reflections From The Summer Of 'Chevron'