FDA Releases Draft Guidance on Labeling Safety - - BioPharm International

ADVERTISEMENT

FDA Releases Draft Guidance on Labeling Safety


FDA has released the second in a series of three guidance documents written to minimize medication errors. The draft guidance offers guidelines to help prescription drug and biologic product manufacturers minimize medication errors and focuses on safety aspects of the container label and carton labeling design. The guidance also provides recommendations for ensuring that crucial elements of a product’s container labels and carton labeling are designed to promote safe dispensing, administration, and use. 

The guidance applies to prescription drug products marketed under an approved new drug application (NDA) or abbreviated new drug application (ANDA); prescription drugs marketed without an approved NDA or ANDA; and biological products marketed under an approved biologics licensing application (BLA). This guidance does not apply to over-the-counter (OTC) drug products.

The first guidance in the series focuses on minimizing risks associated with drug product design and container closure systems. The third planned guidance will focus on best practices for the development and testing of proposed proprietary names to minimize risks associated with drug product nomenclature, such as proprietary names that look or sound like the name of another product (e.g., look-alike or sound-alike names).

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

NIH Seeks to Improve Vaccine Response with New Adjuvants
September 30, 2014
New Report Details Players and Pipelines in the Biosimilar Space
September 30, 2014
Baxter International Plans to Open R&D Center for Baxalta
September 30, 2014
FDA Releases First-Ever Purple Book for Biosimilar Characterization
September 26, 2014
FDA and NIH Win Award for IP Licensing of Meningitis Vaccine
September 26, 2014
Author Guidelines

Click here