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# Senate Committee Pressures FDA on Guidance Process
- URL: https://www.fdaweb.com/senate-committee-pressures-fda-on-guidance-process/
- Published: 2016-05-06T12:00:00.000Z
- Updated: 2026-09-14T21:00:24.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135598

The Senate HELP Committee leadership has written FDA commisioner **Robert Califf** to communicate concern over the agency’s timeliness in finalizing or withdrawing draft guidance documents. In the 5/6 [letter](http://www.help.senate.gov/imo/media/doc/5-6-2016%20FDA%20Guidance%20Letter.pdf?ref=fdaweb.com), the lawmakers criticize the agency for leaving companies in the dark to follow draft recommendations for years, “even if the most up-to-date science would suggest an alternative path. Additionally, it says FDA officials have wrongfully cited draft guidance language in regulatory letters to industry that raise concern about regulated products. The lawmakers further ask the agency to explain how it plans to improve its guidance process.