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pro vyhledávání: '"Amy Ramanadham"'
Autor:
Gerald J. Dal Pan, Jerry Avorn, Lee L. Zwanziger, Esther H. Zhou, Amy Ramanadham, Aaron S. Kesselheim, Cheryl Enger, Zhigang Lu, Michael S. Sinha, Brian M. Lappin, Eric G. Campbell, Frazer A. Tessema, Anita M Loughlin, Paula Rausch
Publikováno v:
The Journal of law, medicineethics : a journal of the American Society of Law, MedicineEthics. 47(3)
Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the m
Autor:
Kesselheim AS; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Sinha MS; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Rausch P; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Lu Z; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Tessema FA; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Lappin BM; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Zhou EH; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Dal Pan GJ; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Zwanziger L; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Ramanadham A; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Loughlin A; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Enger C; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Avorn J; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO., Campbell EG; Aaron S. Kesselheim, M.D., J.D., M.P.H., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Michael S. Sinha, M.D., J.D., M.P.H. is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Paula Rausch, Ph.D., R.N., is with the U.S. Food and Drug Administration in Silver Spring, MD; Zhigang Lu, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Frazer A. Tessema, B.A., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Brian M. Lappin, M.A., is with the U.S. Food and Drug Administration in Silver Spring, MD; Esther H. Zhou, M.D., Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Gerald J. Dal Pan, M.D., M.H.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Lee Zwanziger, Ph.D., is with the U.S. Food and Drug Administration in Silver Spring, MD; Amy Ramanadham, Pharm.D., M.S., is with the U.S. Food and Drug Administration in Silver Spring, MD; Anita Loughlin, Ph.D., is with Optum in Boston, MA; Cheryl Enger, Ph.D., is with Optum in Boston, MA; Jerry Avorn, M.D., is with the Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School; Eric G. Campbell, Ph.D., is with the Center for Bioethics and Humanities at the University of Colorado in Denver, CO.
Publikováno v:
The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2019 Sep; Vol. 47 (3), pp. 430-441.