Zdrowie i gospodarka · 12/10/2011

FDA Releases Guidance on Incorporating Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

The Food and Drug Administration (FDA) has published a guidance document outlining recommendations for incorporating physical-chemical identifiers into solid oral dosage form drug products to prevent counterfeiting, and provides procedures for submitting supporting documentation and requesting approval for post-approval changes.