Pediatric Exclusivity Will Not Irreparably Harm Generic Firms, Court Says
Executive Summary
Exclusivity extensions under FDAMA's pediatric provisions will not cause "irreparable harm" to generic drug manufacturers, D.C. Federal Court Judge James Robertson maintained in an April 20 denial of a generics industry motion for preliminary injunction.
You may also be interested in...
GPhA CEO-Designate Jaeger Has Legal, Regulatory Background
Generic Pharmaceutical Association President & CEO Kathleen Jaeger brings experience in legal and regulatory analysis that could help the trade association in its relations with FDA and in legislative drafting
GPhA CEO-Designate Jaeger Has Legal, Regulatory Background
Generic Pharmaceutical Association President & CEO Kathleen Jaeger brings experience in legal and regulatory analysis that could help the trade association in its relations with FDA and in legislative drafting
NAPM Plans To Reiterate Generic Equivalency To MD Groups: AMA, AAP
The National Association of Pharmaceutical Manufacturers is seeking meetings with professional medical societies to reiterate the message that generic drugs are therapeutically equivalent to reference brands.