FDA Seeks Comment on ICH Ideas to Improve Studies

A set of proposed changes to an international standard to improve the efficiency of clinical trials is being prepared for public comment by the Food and Drug Administration, according to an information collection notice published May 31.

The Federal Register notice (81 Fed. Reg. 34,345) begins the process of obtaining required approval from the White House Office of Management and Budget so the FDA can solicit public comment on the addendum to a draft guidance, E6(R2) Good Clinical Practice, released in September 20159 LSLR 19, 10/2/15, 14 MRLR 657, 10/7/15. The changes proposed by the International Council ...