ABSTRACT
FDA finds that: (i) Any of the conditions in paragraphs (b)(1)(i) through (b)(1)(xi) of this section
apply; or (ii) The investigational plan or protocol(s) is not reasonable as a bona fide scientific
plan to determine whether or not the drug is safe and effective for use; or (iii) There is convincing evidence that the drug is not effective for the purpose for
which it is being investigated. (3) FDA may propose to terminate a treatment IND if it finds that: (i) Any of the conditions in paragraphs (b)(1)(i) through (x) of this section apply; or (ii) Any of the conditions in § 312.42(b)(3) apply. (c) Opportunity for sponsor response. (1) If FDA proposes to terminate an IND, FDA
will notify the sponsor in writing, and invite correction or explanation within a period of 30 days.
