In Brief: SUPAC
This article was originally published in The Tan Sheet
Executive Summary
SUPAC: Draft guidance allows lower strengths for topical drug products such as gels, creams and ointments through a prior approval supplement instead of an NDA or an ANDA filing. The Scale-up and Post-Approval Changes Guidance for Semi-Solid Dosage Forms is being circulated in draft form for industry comment. The draft guidance would ease requirements for changes to a lower dosage strength by eliminating the need for in vivo studies in certain cases. In vitro release testing would replace the in vivo study requirement. FDA is planning a public workshop to discuss the draft SUPAC-SS guidance prior to its final release...
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