Buckle Up For Brand Take Off: FDA's Checklist For Pilot Participants
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed pilot to expedite proprietary name reviews would require sponsors to submit more comprehensive safety data, shifting the burden of testing look-alike, sound-alike names for medication errors. CDER and CBER recommend applicants submit the following information:
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning