In accordance with the United States Food & Drug Administration’s (“FDA”) 2018 Compounding ..
On November 26, 2018, the Food & Drug Administration (FDA) announced its intent “to modernize the FDA’s ..
The Office of the Inspector General (OIG) published a report in September 2018 after a review of the Food ..
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical ..
As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency ..
In May, the Trump Administration announced its Blueprint to Lower Drug Prices and HHS Secretary Azar ..
On July 18, 2018, after months of alluding to the various aspects of an upcoming “Biosimilar Action ..
Congress is in session this week with six important health care hearings, including hearings on Medicare ..
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 ..