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 ...

The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions. Background The agency, through its Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), has decided to adopt the Logical Observation Identifiers Names and Codes (LOINC) as "part of a larger FDA effort to align the use of data standards for clinical research with ongoing ...

The FDA released new draft guidance for industry on Tuesday titled, Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes . Classification product codes are used by FDA to help identify, track, and reference medical device types. They are standardized alphanumeric strings used to quickly identify the product's characteristics, device class, and predicate devices. The purpose of the draft guidance is to educat...