FDA Releases Draft Guidance on Labeling Safety - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Releases Draft Guidance on Labeling Safety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 The draft guidance offers guidelines to help prescription drug and biologic product manufacturers minimize medication errors and focuses on safety aspects of the container label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).

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests

Click here