IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more
Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more