FDA Adds OTC Monograph Staff By Shifting CDER Appropriations
Executive Summary
CDER will add five staff members to expand to 23 the number committed to working on the monograph program, an unexpected development for the OTC industry especially in light of FDA's proposals for monograph program user fee.
You may also be interested in...
OTC Monograph Application Reviews Get Deadlines, Not GRASE Flexibility
Changes to FDA's interpretation of the GRASE standard it uses to evaluate ingredient proposals would go further to opening the US monograph process to innovation and progress than setting deadlines for the reviews, industry stakeholders say.
OTC Monograph Application Reviews Get Deadlines, Not GRASE Flexibility
Changes to FDA's interpretation of the GRASE standard it uses to evaluate ingredient proposals would go further to opening the US monograph process to innovation and progress than setting deadlines for the reviews, industry stakeholders say.
OTC Drug Industry Could Stand To Gain With 'Pragmatist' In White House
With the Trump administration ahead, CHPA's highest regulatory priorities include eliminating a requirement from the Obama era that consumers get a prescription in order to pay for OTC drugs with pre-tax savings accounts and improving the Nixon-era monograph program.