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Legislators On OTC Monograph Reform: What Took You So Long?

 
• By Malcolm Spicer

"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.

Capitol House

Members of a House subcommittee don't doubt whether FDA's OTC drug monograph program needs changes, but several want to know what took the agency so long to ask for help.

The Energy and Commerce Committee's Health subcommittee heard testimony on Sept. 13 from FDA drug center chief Janet Woodcock and...

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