FDA Issues New Set of Guidances Focused on Generic Drug Submissions and…
In late January 2022, the United States Food and Drug Administration (FDA) issued three guidances (two final and one revised…
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March 2022
FDA-Duke to Host Public Workshop Focused on Key Competencies for Opioid…
Duke-Margolis Center for Public Policy and the Food and Drug Administration (FDA) are hosting a virtual workshop on April 4th and…
OPDP Issued Six Letters in 2021
The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021. Four were…
Califf Narrowly Voted by Senate to Be Next FDA Commissioner
Robert Califf was narrowly approved in the U.S. Senate and will return to the FDA as its next commissioner. With this in mind, we…
CME-MOC Webinar Series to Update Clinicians on Latest in NASH…
NASH (non-alcoholic steatohepatitis) is a liver disorder characterized by accumulation of fat in the liver and liver scarring. It…
Michigan Makes Changes to Laws Surrounding Pharmacy Benefit Managers
In mid-February 2022, Michigan Governor Gretchen Whitmer signed several pharmacy benefit manager (PBM) reforms into law, including…
Teva Reaches $225 Million Settlement with Texas Over Opioid Claims
On Monday, February 14, 2022, Texas Attorney General Ken Paxton announced a $225 million settlement with Teva Pharmaceutical…
Pharmacists’ Role to Expand Over the Next Decade
According to recent research from the Columbia University Mailman School of Public Health and Express Scripts Pharmacy,…
MedPAC Presents MA Findings, Including Increased Spending
In mid-January 2022, MedPAC held its public meeting virtually via GoToWebinar, where the Commission covered a multitude of topics,…
Ten Individual Indicted in $300 Million Healthcare Fraud
Earlier this year, Chad E. Meacham, United States Attorney for the Northern District of Texas, announced a $300 million healthcare…