HHS Issues Final Rule that Expands the Requirements for Disclosure of Clinical Trial Data to ClinicalTrials.gov

King & Spalding
Contact

On September 21, 2016, the Department of Health and Human Services (HHS) published a final rule that greatly expands the information that sponsors of “applicable drug clinical trials” and “applicable device clinical trials” must submit to ClinicalTrials.gov for subsequent public disclosure. The new rule comes into effect on January 18, 2017 and responsible parties will have until April 18, 2017 to achieve compliance. Detailed new regulations – titled “Clinical Trials Registration and Results Information Submission” – will be codified at 42 C.F.R. Part 11. Major changes from prior law (until now existing only in statute at 42 U.S.C. § 282) include: (1) a new requirement for the submission of results and adverse events from applicable clinical trials of FDA-regulated drugs and devices not yet approved for any use; (2) expansion of the range of adverse events that must be disclosed; (3) a new requirement for the submission of study protocols and statistical plans accompanying results; and (4) clarification of the potential criminal and civil legal consequences of non-compliance. In addition, the rule sets out new requirements for all clinical trials that are funded by the National Institutes of Health (NIH).

This client alert focuses on those changes that are likely to have the greatest potential impact on pharmaceutical and medical device companies. Be aware, however, that the Final Rule is lengthy and contains additional detail.

Please see full publication below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© King & Spalding | Attorney Advertising

Written by:

King & Spalding
Contact
more
less

King & Spalding on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide