This course provides an overview of the laws and regulations governing drugs and medical devices. Emphasis is placed upon the various regulatory pathways through which drugs and medical devices enter the U.S. market and the enforcement tools available to the U.S. Food and Drug Administration and U.S. Department of Justice in regulating the health care products industries. Pertinent state laws, federal, state, and industry guidance documents, and relevant intellectual property laws are also considered.
|T 4:00-5:50 PM||Klein 7B|
No Registration Restrictions.