Milwaukee partner Robyn Shapiro and counsel Leslie Tector wrote an article for Bloomberg BNA’s Medical Research Law & Policy Report, titled, “New FDA Informed Consent Requirements for Applicable Clinical Trials: Practical Approaches for Implementation.

Sponsors, investigators, and institutional review boards for applicable clinical trials regulated by the Food and Drug Administration (FDA) initiated on or after March 7, 2012, must assure compliance with an additional informed consent requirement after a revision of FDA regulations.

Robyn and Leslie address practical questions relating to implementation of the new regulatory requirements, such as the definition of “applicable clinical trial,” the informed consent language, implications for studies conducted outside the United States, and whether the requirement is retroactive.

Source: Bloomberg BNA – Medical Research Law & Policy Report
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