FDA's 'Shot Across the Bow' Warning to Agena, Natco; Lupin, Glenmark, Natco Recall US Products

The U.S. Food and Drug Administration (FDA) has issued warning letters to Agena Bioscience and Natco Pharma, highlighting regulatory concerns. Agena Bioscience received a warning for its RUO-labeled diagnostics, described as a 'Shot Across the Bow' for the industry, signaling a strict stance on regulatory compliance. Similarly, Natco Pharma was warned regarding its Telangana facility, marking a significant regulatory action. Additionally, pharmaceutical companies Lupin, Glenmark, and Natco have initiated recalls of certain products from the US market, although the specific reasons for these recalls were not detailed in the reports.