Table 3.

Regulatory Documents with Contributions from FDA OWH-Funded Research

	Year released
Guidance for industry: nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals	2005
Guidance for industry: E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs	2005
Guidance for industry and FDA staff: saline, silicone gel, and alternative breast implants	2006
Draft guidance for industry: vaginal microbicides: development for the prevention of HIV infection	2012
Draft guidance for industry: drug interaction studies-study design, data analysis, implications for dosing, and labeling recommendations	2012
International Standard Safety Standard for CT: International Electrochemical Commission, Medical electrical equipment: IEC 60601-2-44	2012
International Safety Standard for sunlamp products; International Electrochemical Commission, Household and similar electrical appliances: IEC 60335-2-27	2012
Guidance for industry and FDA staff: evaluation of sex differences in medical device clinical studies	2014