CHPA Regulatory & Scientific Conference In Brief
This article was originally published in The Tan Sheet
Executive Summary
OTC monograph finalization may never end, FDA exec suggests; agency official advises coloring inside the monograph lines; OTC adverse event reports fell about 19% in 2011; supplement AER practices can mitigate rising insurance rates.
You may also be interested in...
OTC Monographs Face Obsolescence In Shadow Of NDA Products
Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.
OTC Monographs Face Obsolescence In Shadow Of NDA Products
Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.
OTC Monographs Face Obsolescence In Shadow Of NDA Products
Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.