By James E. Valentine* & Anne Marie Murphy –
The National Institutes of Health (“NIH”) just extended the comment period for its Notice of Proposed Rulemaking on clinical trial registration and results submission (“NPRM”) until March 23, 2015. As we previously reported, the NPRM proposes to expand and clarify many of FDAAA’s requirements for submitting registration and summary results information for specified clinical trials of drugs, biologics, and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov.
This month-long extension will provide current and future “responsible parties” of “applicable clinical trials,” as well as other stakeholders, additional time to weigh in on NIH’s proposed changes (e.g., requiring results for trials of products that are not approved), as well as areas where the Agency has requested specific feedback (e.g., whether to require lay and/or technical results summaries). For a synopsis of the changes proposed in the NPRM, see our previous posts here and here. Comments can be submitted to docket number NIH-2011-0003 at Regulations.gov.
*Admitted only in Maryland. Work supervised by the Firm while D.C. application pending.