Comment from AIM at Melanoma Foundation

Summary: AIM at Melanoma, a nonprofit organization, supports the Haystack Project's petition for rulemaking to clarify how the "adequate and well-controlled" standard should be applied to rare diseases and orphan-designated products. They argue that the proposed amendments to 21 CFR § 314.126(b) and 21 CFR § 312.47 will improve regulatory predictability and ensure that study designs are fit-for-purpose for small, heterogeneous patient populations.