To me, the FDA has always seemed like a large, intimidating and confusing organization. I always assumed it was because I got lost in the science of the administration. Turns out, I’m not the only one to struggle with the FDA.
Last week, senior faculty from the Bloomberg School of Public Health, Harvard Medical School/Brigham and Women’s Hospital, Yale Medical School and Yale Law School, published in JAMA and the Bloomberg School’s website a Blueprint for Transparency that gives 18 recommendations in five principal areas to the FDA in an effort to be more transparent.
Each of the five areas push towards helping manufacturers and researchers make more progress by asking for more information on why decisions were made and where applications for approval are in the process. In addition, all 18 recommendations would not require new legislation from Congress and respects trade secret legal protections.