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The FDA’s final guidance on non-proprietary naming for biologics directs both reference products and biosimilars to share the same core name, with both products bearing a different four-letter suffix. Read More
Premier’s device has been cleared to test for amphetamine, methamphetamine, marijuana, cocaine, opiates, and phencyclidine, in addition to the two new assays. Read More
Endo argued that the FDA’s handling of bulk compounding laws violated the Drug Quality and Security Act when it treated the legislation as non-binding guidance instead of as a legal mandate. Read More
The enforcement action “should send a clear message to the burgeoning iV therapy industry and sellers of all healthcare products,” said FTC Chairman Joe Simons. Read More