§ 11.42 For which applicable clinical trials must clinical trial results information be submitted?

(a) Applicable clinical trials for which the studied product is approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with § 11.54, clinical trial results information must be submitted for any applicable clinical trial for which the studied product is approved, licensed, or cleared by FDA for which submission of clinical trial registration information is required in accordance with the following: