Areta Kupchyk

In Search Of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization With ISO 13485:2016

FDA's Major Statement: The Agency's Recent Direct-To-Consumer CCN Final Rule, Q&A Guidance And Enforcement Trends

OMB Releases Artificial Intelligence Memorandum To Federal Agencies

FDA Releases First New COVID-19 Vaccine BLA Guidance Since 2020

President Biden Issues Executive Order On Use Of Artificial Intelligence In Healthcare Settings

FDA Issues Revised Draft Guidance On "Scientific Information On Unapproved Uses Communications"

FDA Publishes Long-Awaited In Vitro Diagnostics Proposed Rule – Medical Device Regulations Would Apply To Laboratory Developed Tests

FDA And Prescription Drug Use Related Software – FDA's Draft PDURS Guidance Answers Years-Old Questions And Introduces New Ones

Are You Not Interchanged? FDA's Recent Biosimilar Labeling Guidance Chips Away At Interchangeable Product Advantages

Competing Rulings Issued On Access To Mifepristone, Fda Seeks Emergency Appellate Relief