FDA Guidance On Health Care Economic Data Is Coming In 2015

Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.

Having failed to meet its year-end 2014 target date, FDA is now eyeing 2015 to issue guidance governing pharmaceutical sponsors’ interactions with formulary committees on health care economic information.

In a Dec. 22 letter to two law firms that represent the Medical Information Working Group (MIWG), Associate Commissioner for Policy Leslie Kux said the agency’s current goal...

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