Drug Manufacturers need to provide customers with vital information on their product labels such as product ingredients and the possible side effects of the product. This information has become a top priority with any drug manufacturer. Unfortunately we have seen many incidents where products did not contain the proper warnings and the outcomes can be dangerous. That is one of the main reasons the FDA is re-opening the possibility of allowing generic drug manufacturers to update label contents without their approval.
Major drug manufacturers have argued that these smaller companies do not have the resources and research capabilities to properly update labeling changes while others suggest the FDA come up with a rapid approval process for both major and generic drug manufacturers.
A final ruling is expected to come by September 30th 2015; regardless of the outcome drug manufacturers need to be prepared to update and implement any label changes and have it available to the consumers or face possible recalls and fines. If you have questions or concerns on your companies current labeling implementation please contact Pragmatyxs and we can further assist you.
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