“The new proposal aims to fulfill a European Parliament request for more stringent med-tech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.”  Sound familiar? You might be surprised to learn that this excerpt was not in reference to FDA.

It’s official! According to the new guidance released on the FDA’s website all applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include this specific statement that refers to the trial’s description on http://www.clinicaltrials.gov: