In a highly anticipated step, which had been teased by agency leadership in their public appearances ..
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening ..
Businesses engaged in human drug compounding, both traditional pharmacies and the more recently created ..
On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released ..
This week, the House is set to vote on Right to Try legislation which has gained the support of FDA Commissioner ..
In 2017, FDA issued only 44 Warning Letters to medical device establishments. Of those, 11 were related ..
This week, the focus shifts back to the Congressional push around addressing the opioid epidemic after ..
On April 17, 2018, FDA announced its plan to launch the Medical Device Safety Action Plan: Protecting ..
Congress will continue its work in addressing the opioid crisis this week with a hearing in the Senate ..
Last month, the Department of Health and Human Services’ Office of Inspector General (OIG) released ..