The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...

Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit. The opinion hinges on an important concept linked to the patenting of pharmaceuticals, the use of CMOs and the manufacturing processes necessary to produce pharma...