GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA
This article was originally published in The Pink Sheet
Report to key US legislators could boost efforts to revamp approaches to making nonprescription ingredients available.
You may also be interested in...
Senate pandemic economic relief legislation legislation would reform monograph drug program and allow purchases of OTC drugs with pre-tax health savings accounts. But lingering disagreements between Democrats and Republicans blocked the Senate's passage of the bill on 25 March.
CDER agrees to protect DSMs confidential business information by redacting most correspondence but says general meeting minutes will be made public. To address TEA sponsors' concerns about disclosing proprietary information, "in some situations FDA may hold private meetings with sponsors who request them without subsequently disclosing proprietary information," CDER Division of Nonprescription Drug Products responds to DSM request.
"If the system is broken … my gosh, does it take 45 years for the FDA to say, 'we need help'?" US Rep. Joe Barton, R-TX, asks at House health subcommittee hearing on proposal to streamline the OTC monograph program and establish a user fee program to support FDA's work.