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FDA and Prescription Drugs: A Free, Online Course from HarvardX

Available March 26, 2019, a new course “FDA and Prescription Drugs: Current Controversies in Context” will be offered at no cost via the HarvardX online platform (part of the non-profit EdX consortium).  It is designed around a 6-week, self-paced schedule, and features expert guest speakers including former FDA commissioner Margaret Hamburg.

Video lectures, delivered by Harvard faculty from the Program on Regulation, Therapeutics, and Law (PORTAL), cover FDA history, expedited drug development, Right-to-Try, industry user fees, cancer treatments, Orphan drugs, dietary supplements, high prices, post-market surveillance, advertising, and much more. Starts March 26. Any interested person can preview the course trailer and enroll here (open to everyone).  #HarvardXFDA

Jonathan Darrow

Jonathan Darrow

Dr. Jonathan J. Darrow is a an Assistant Professor at Harvard Medical School and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham & Women's Hospital. He received his research doctorate (SJD) in pharmaceutical policy from Harvard University, where he completed an LLM program in intellectual property (waived), as well as degrees in genetics (BS), law (JD), and business (MBA) from Cornell University, Duke University, and Boston College. After qualifying for the California and Patent bars in 2001 and 2002, Dr. Darrow served as a senior law clerk at the U.S. Court of Appeals for the Federal Circuit, worked in private law practice at Cooley LLP and Wiley Rein LLP, taught on the faculties of four universities and for the World Intellectual Property Organization, authored several law textbooks, supported the intellectual property divisions of WHO and WTO, lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs. He is an author of several textbooks, including Cyberlaw: Management & Entrepreneurship (Cengage 2012; Aspen 2015), The Legal and Ethical Environment of Business (Aspen 2014 and Wolters-Kluwer 2d ed. 2018), and Business Law and Management for Entrepreneurs (Edward Elgar, forthcoming). He has lectured widely on issues of FDA regulation, and published numerous articles on issues such as expanded access, the breakthrough therapy designation, competition policy, pharmaceutical patenting, gene therapies, drug efficacy, biological products, therapeutic vaccines, and expedited development and approval programs.

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