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Industry groups are worried that a section of the proposed FDA and NIH Workforce Authorities Modernization Act would exempt biologics from adhering to U.S. Pharmacopeial standards for quality. Read More
A U.S. district court has dismissed patent infringement claims against Hikma Pharmaceuticals, ruling that Takeda Pharmaceuticals USA lacked any “plausible claim to relief” in the case. Read More
The FDA is calling out two dietary supplement makers for a host of issues, including drug-like promotional claims and GMP issues that render their products adulterated. Read More