IRB: Written Procedures Updated, FDA Dropped Its Restrictions

The FDA has lifted restrictions on an institutional review board (IRB) after the board updated written procedures for meeting minutes and other regulatory requirements in response to a warning letter. The agency had said it would not approve new studies of the South Pasadena, Calif., IRB at MI Hope and forbade the board from enrolling new subjects in ongoing studies until it updated certain written procedures, according to an Oct. 19 warning letter posted on the FDA’s website last month. The IRB has updated its procedures and the FDA has dropped the restrictions, John Martin, the principal investigator of a study cited in the letter, said.
Clinical Trials Advisor