OTC Antiseptic Wash Industry Disputes FDA Cost Estimate For Proposed 'Rub' Monograph
This article was originally published in The Tan Sheet & The Rose Sheet
Executive Summary
FDA’s estimate for the economic impact of its proposal requiring additional safety and efficacy data for OTC antiseptic rub excludes the current benefit the products provide in fighting infection, says the American Cleaning Institute. Industry places annual cost over a 10-year-period at as much as $6.7m.
You may also be interested in...
Intangible Benefits Are Influential In OTC Switch Decisions – CDER’s Ganley
Non-measurable benefits can tip the scales in the benefit/risk consideration of an OTC switch NDA, suggests Charles Ganley, director of CDER's Office of Drug Evaluation IV. One way to look at non-measurable benefits is how OTC ingredients "lower the threshold” for patient “misery” prior to seeking relief, he says.
Industry Cost Estimates For Proposed Antibacterials Rule Dwarf FDA’s
In comments to FDA, the Personal Care Products Council and American Cleaning Institute challenge agency cost projections and question the need for clinical study data to back the efficacy of antibacterial hand-wash products, as called for in a proposed rule issued by the agency in December 2013. Groups say manufacturers require guidance and request an extension of the deadline for data submissions, current set for December 2014.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.