Council, J&J press FDA on sunscreen monograph
This article was originally published in The Rose Sheet
Executive SummaryThe Personal Care Products Council requests a meeting with FDA to discuss amendments to sunscreen ingredient monograph proposed in 2007. In a Nov. 3 1letter to Principal Deputy Commissioner Josh Sharfstein, the council urges the agency "to finalize the sunscreen regulations in a way that allows for labeling that educates and helps consumers protect themselves from the dangers of sun exposure." A Council rep said the trade group has not heard back from FDA. Johnson & Johnson and subsidiary Neutrogena sent a 2letter Nov. 5 voicing the company's concerns about proposal to cap sunscreen label claims at SPF 50. "Any proposed cap on SPF labeling is not necessary and will significantly contribute to reduced innovation and likely reduced communication spends within our industry," J&J says
You may also be interested in...
US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.
Sanofi eyes $1bn top line growth from OTC switches of ED drug Cialis and flu drug Tamiflu after they launch by 2026, says CEO Paul Hudson. Like switch consultants, though, he acknowledges the high bar for approval moving additional Rx ingredients to OTC.
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.