Small Biotech, Device Companies Face Research Oversight Hurdles

Smaller drug and device companies will be more vulnerable to compliance pitfalls than industry giants like Pfizer and Johnson & Johnson when changes to HHS research oversight regulations take effect in January.

Clinical trials done to support applications for product marketing approval must follow the Food and Drug Administration’s human subject protection regulations, which differ from the revised Health and Human Services regulations known as the Common Rule.

Both sets of regulations include requirements to shield research subjects from undue harm, such as by ensuring research volunteers know about a study’s risks and benefits before they agree to enroll. ...