Anthera Completes Special Protocol Assessment With FDA And Receives EMEA Scientific Advice On Development Path Toward ... (Medical News Today)
Anthera Pharmaceuticals announced they have reached agreement with the U.S. Food and Drug Administration (FDA) on a Phase 3 protocol for varespladib (A-002) in acute coronary syndrome (ACS) under the FDA's Special Protocol Assessment procedure.

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug ... (U. S. Food and Drug Administration)
The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.

FDA Warns Companies To Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products And Topical Drug ... (Medical News Today)
The U.S. Food and Drug Administration (FDA) announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.