
FDA Publishes Guidance on NDC Codes
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
On Dec. 18, 2019, FDA published
The guidance addresses labeling of multi-market approved products (MMA products); submissions of new drug application (NDA) and biologic license application (BLA) supplements of an MMA product; registering, listing, and proposing an NDC for an MMA product; importation of an MMA product; and supply chain issues.
Source:
Newsletter
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.