OTC Regulatory Pathway Needs NDA Flexibility, Monograph Scope – Sharfstein
This article was originally published in The Pink Sheet Daily
Executive Summary
Former FDA deputy commissioner Joshua Sharfstein, noting public health advocates’ disappointment with results from Sunscreen Innovation Act requirements, proposes an OTC drug review pathway that combines elements of the NDA and monograph systems and would require legislation to create.
You may also be interested in...
Woodcock To Be Acting US FDA Commissioner; Sharfstein Tops Biden's List Of Candidates For Post
Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.
Unilever Squelches Dr. Squatch Comparative Claims In NAD Forum; Advertiser Can Keep Its 'Sh*t List’
Dr. Squatch was able to substantiate that it uses “no harmful ingredients” as well as certain claims about avoiding a “Sh*t list” of ingredients, but agreed to modify other claims the National Advertising Division deemed falsely disparage competitor products, such as Unilever’s Dove personal-care brand.
Refillable Personal-Care Packaging: Experts Discuss Contamination Risks, Liability, MoCRA Compliance
Personal-care companies navigating a growing patchwork of state recycling laws are exploring refillable packaging options, but there are serious concerns and questions to consider before embarking down this potentially risky path, experts said at IBA’s Supply Chain & Sustainability Conference.