• Regulatory NewsRegulatory News

    FDA announces plans to revamp national drug code

    The US Food and Drug Administration (FDA) on Monday proposed an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years.   The rule would retain the three-segment code consisting of the labeler code, the product code and the packaging code. The NDC is used to register and track pharmaceutical products through the supply chain.   Under...
  • Regulatory NewsRegulatory News

    FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal

    After a decade of consideration, the US Food and Drug Administration (FDA) on Tuesday finalized new regulations governing drug establishment registration and drug listing for foreign and domestic firms, though the agency stopped short of finalizing several provisions that commenters took issue with. The new rule, expected to take effect in 90 days, includes amendments that reorganize, modify and clarify FDA regulations on who must register establishments and list human d...