DOCSLIB.ORG

FDA Dsarm-AADPAC September 10 2020 a Matter of Record (301)

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
FDA Dsarm-AADPAC September 10 2020 a Matter of Record (301) 1 FDA DSaRM-AADPAC September 10 2020 1 FOOD AND DRUG ADMINISTRATION 2 CENTER FOR DRUG EVALUATION AND RESEARCH 3 4 5 JOINT MEETING OF THE DRUG SAFETY AND 6 RISK MANAGEMENT ADVISORY COMMITTEE (DSaRM) AND THE 7 ANESTHETIC AND ANALGESIC DRUG PRODUCTS 8 ADVISORY COMMITTEE (AADPAC) 9 10 11 12 Virtual Meeting 13 14 15 Thursday, September 10, 2020 16 9:02 a.m. to 5:10 p.m. 17 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 2 1 Meeting Roster 2 DESIGNATED FEDERAL OFFICER (Non-Voting) 3 Philip Bautista, PharmD 4 Division of Advisory Committee and 5 Consultant Management 6 Office of Executive Programs, CDER, FDA 7 8 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE 9 MEMBERS (Voting) 10 Marie R. Griffin, MD, MPH 11 Professor of Health Policy, Emerita 12 Department of Health Policy 13 Vanderbilt University 14 Nashville, Tennessee 15 16 Sonia Hernandez-Diaz, MD, DrPH 17 (Chairperson) 18 Professor of Epidemiology 19 Department of Epidemiology 20 Harvard T.H. Chan School of Public Health 21 Boston, Massachusetts 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 3 1 Collin A. Hovinga, PharmD, MS, FCCP 2 Senior Vice President 3 Clinical and Scientific Development 4 The Institute for Advanced Clinical Trials (I-ACT) 5 for Children 6 Clinical Associate Professor of Pharmacy 7 University of Texas at Austin 8 College of Pharmacy 9 Austin, Texas 10 11 Steve Meisel, PharmD, CPPS 12 System Director of Medication Safety 13 M Health Fairview 14 Minneapolis, Minnesota 15 16 Lewis S. Nelson, MD 17 Professor and Chair 18 Department of Emergency Medicine 19 Chief, Division of Medical Toxicology 20 Rutgers New Jersey Medical School 21 Newark, New Jersey 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 4 1 Soko Setoguchi, MD, DrPH 2 Professor of Medicine and Epidemiology 3 Rutgers Robert Wood Johnson Medical School 4 Rutgers University 5 New Brunswick, New Jersey 6 7 DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE 8 MEMBERS (Non-Voting) 9 Reema J. Mehta, PharmD, MPH 10 (Industry Representative) 11 Senior Director, Head of Risk Management and 12 Safety Surveillance Research 13 Pfizer, Inc. 14 North Peapack, New Jersey 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 5 1 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY 2 COMMITTEE MEMBERS 3 (Voting) 4 Basavana G. Goudra, MD, FRCA, FCARSCI 5 Clinical Associate Professor of Anesthesiology and 6 Critical Care Medicine 7 Director of Endoscopy Anesthesia Services at the 8 Penn Presbyterian Medical Center 9 Perelman School of Medicine 10 Hospital of the University of Pennsylvania 11 Philadelphia, Pennsylvania 12 13 Jennifer Higgins, PhD 14 (Consumer Representative) 15 Owner 16 CommonWealth GrantWorks 17 Northampton, Massachusetts 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 6 1 Maryam Jowza, MD 2 Assistant Professor of Anesthesiology and Pain 3 Management 4 University of North Carolina-Chapel Hill 5 Chapel Hill, North Carolina 6 7 Maura S. McAuliffe, CRNA, MSN, MSNA, PhD, FAAN 8 Professor, College of Nursing 9 Director, Nurse Anesthesia Program 10 East Carolina University 11 Greenville, North Carolina 12 13 Abigail B. Shoben, PhD 14 Associate Professor, Division of Biostatistics 15 College of Public Health 16 The Ohio State University 17 Columbus, Ohio 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 7 1 Michael Sprintz, DO, DFASAM 2 Clinical Assistant Professor, Division of Geriatric 3 and Palliative Medicine 4 University of Texas Health Science Center 5 CEO and Chief Medical Officer 6 Sprintz Center for Pain, PLLC 7 Sprintz Center for Recovery, PLLC 8 Shenandoah, Texas 9 10 Richard D. Urman, MD, MBA 11 Director, Center for Perioperative Research 12 Associate Chair for Dana-Farber Cancer Institute 13 Associate Professor of Anesthesia, Harvard 14 Medical School 15 Brigham and Women's Hospital 16 Boston, Massachusetts 17 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 8 1 Sherif Zaafran, MD, FASA 2 President, Texas Medical Board 3 Vice-Chair, Clinical Governance Board 4 US Anesthesia Partners Gulf Coast 5 Memorial Healthcare System Acute and Chronic Pain 6 Committee, Houston 7 Memorial Healthcare System Perioperative 8 Committee, Houston 9 US Anesthesia Partners 10 Houston, Texas 11 12 13 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 9 1 Kevin L. Zacharoff, MD, FACIP, FACPE, FAAP 2 Faculty and Clinical Instructor 3 Course Director Pain and Addiction 4 Distinguished Visiting Scholar in Medical 5 Humanities, Compassionate Care, and Bioethics 6 Renaissance School of Medicine at 7 Stony Brook University 8 Consultant to the Ethics Committee 9 Stony Brook University Hospital 10 Ethics Committee Chair 11 St. Catherine of Siena Medical Center 12 Smithtown, New York 13 14 ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY 15 COMMITTEE MEMBER 16 (Non-Voting) 17 Jay Horrow, MD, MS, FACC 18 (Industry Representative) 19 Clinical Lead, Cardiovascular Drug Development 20 Bristol-Myers Squibb 21 Lawrenceville, New Jersey 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 10 1 TEMPORARY MEMBERS (Voting) 2 Maryann Amirshahi, PharmD, MD, MPH, PhD 3 Associate Professor of Emergency Medicine 4 Georgetown University School of Medicine 5 Department of Emergency Medicine 6 MedStar Washington Hospital Center 7 Medical Toxicologist 8 National Capital Poison Center 9 Washington, District of Columbia 10 11 Brian T. Bateman, MD 12 Vice Chair for Faculty Development 13 Chief, Division of Obstetric Anesthesia 14 Department of Anesthesiology 15 Co-Director, Harvard Program on Perinatal and 16 Pediatric Pharmacoepidemiology 17 Division of Pharmacoepidemiology and 18 Pharmacoeconomics, Department of Medicine 19 Brigham and Women's Hospital 20 Associate Professor, Harvard Medical School 21 Boston, Massachusetts 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 11 1 Phillip O. Coffin, MD, MIA, FACP, FIDSA 2 Director of Substance Use Research 3 San Francisco Department of Public Health 4 Division of HIV, ID & Global Medicine 5 University of California, San Francisco 6 San Francisco, California 7 8 Alex Davis, PhD 9 Associate Professor 10 Department of Engineering and Public Policy 11 Carnegie Mellon University 12 Pittsburgh, Pennsylvania 13 14 Dean Follmann, PhD 15 Assistant Director for Biostatistics 16 National Institute of Allergy and Infectious 17 Diseases 18 National Institutes of Health (NIH) 19 Bethesda, Maryland 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 12 1 Adam J. Gordon, MD, MPH, FACP, DFASAM 2 Elbert F. and Marie Christensen Endowed Research 3 Professorship 4 Professor of Medicine and Psychiatry 5 University of Utah School of Medicine 6 Chief, Addiction Medicine 7 Salt Lake City VA Health Care System 8 Salt Lake City, Utah 9 10 Traci C. Green, PhD, MSc 11 Professor 12 Heller School for Social Policy and Management 13 Director, Opioid Policy Research Collaborative 14 Brandeis University 15 Waltham, Massachusetts 16 17 Stefan G Kertesz, MD, MSc 18 Professor of Medicine 19 University of Alabama at Birmingham Schools of 20 Medicine & Public Health 21 Birmingham VA Medical Center 22 Birmingham, Alabama A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 13 1 Erin E. Krebs, MD, MPH 2 Chief of General Internal Medicine 3 Minneapolis VA Health Care System 4 Professor of Medicine 5 University of Minnesota 6 Minneapolis, Minnesota 7 8 Dermot P. Maher, MD, MS, MHS 9 Assistant Professor 10 Department of Anesthesia and Critical Care 11 Medicine, Chronic Pain Division 12 Johns Hopkins School of Medicine 13 Baltimore, Maryland 14 15 Brandon D.L. Marshall, PhD 16 Associate Professor 17 Department of Epidemiology 18 Brown University School of Public Health 19 Providence, Rhode Island 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 14 1 Joseph P. O'Brien, MBA 2 (Patient Representative) 3 President, CEO, & Patient 4 National Scoliosis Foundation 5 Stoughton, Massachusetts 6 7 Jon E. Zibbell, PhD 8 Senior Public Health Scientist 9 Behavioral Health Research Division 10 RTI International 11 Atlanta, Georgia 12 13 14 15 16 17 18 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 15 1 FDA PARTICIPANTS (Non-Voting) 2 Judy Staffa, PhD, RPh 3 Associate Director for Public Health Initiatives 4 Office of Surveillance and Epidemiology (OSE) 5 CDER, FDA 6 7 Jana McAninch, MD, MPH, MS 8 Senior Medical Epidemiologist 9 Division of Epidemiology II (DEPI-II) 10 Office of Pharmacovigilance and Epidemiology (OPE) 11 OSE, CDER, FDA 12 13 Rigoberto Roca, MD 14 Director (Acting) 15 Division of Anesthesiology, Addiction Medicine 16 and Pain Medicine (DAAP) 17 Office of Neuroscience (ON) 18 Office of New Drugs (OND), CDER, FDA 19 20 21 22 A Matter of Record (301) 890-4188 FDA DSaRM-AADPAC September 10 2020 16 1 Mark Liberatore, PharmD, RAC 2 LCDR, United States Public Health Service (USPHS) 3 Deputy Director for Safety 4 DAAP, ON, OND, CDER, FDA 5 6 Josh Lloyd, MD 7 Medical Officer Team Leader 8 Controlled Substance Staff (CSS) 9 Office of the Center Director, CDER, FDA 10 Silvia Calderon, PhD 11 Senior Pharmacologist 12 CSS, OCD, CDER, FDA 13 14 Yueqin Zhao, PhD 15 Lead Mathematical Statistician 16 Division of Biometrics VII 17 Office of Biostatistics 18 Office of Translational Sciences, CDER, FDA 19 20 21 22 A Matter of Record (301) 890-4188
Load more

Recommended publications
  • November Feature Article Employment in New Jersey’S Labor Areas Annual Review and Outlook Series
    November Feature Article Employment in New Jersey’s Labor Areas Annual Review and Outlook Series he national and state economic outlooks are both appreciably more positive than at this time last year. As 2009 ends, most experts believe that the economy bottomed out in theT third quarter and that a fragile recovery is underway. The most recent Gross Domestic Product (GDP) estimates support this view. In the third quarter, GDP grew at an annualized rate of 3.5 percent, a marked improvement over the huge losses suffered in the fourth quarter of 2008 and the first quarter of this year. Since then, GDP declined by 0.7 percent in the second quarter and had positive growth of 3.5 percent in the third quarter. Most experts believe that the economy will grow between 2.5 to 3.0 percent in 2010. Personal consumption expenditures in the third quarter were up 3.4 percent, after declin- ing in three of the previous four quarters. A challenge going forward will be to sustain con- sumer spending in the face of some serious obstacles, some of which are discussed below. The outlook for the labor market is far less optimistic. The labor market economy will es- sentially remain stagnant for a while longer. The national unemployment rate is now in double digits for the first time since the 1981-1982 recession. The New Jersey unemployment rate is at the highest level since early 1977. In October 2009, the national unemployment rate increased to 10.2 percent while the New Jersey unemployment rate rose to 9.7 percent.
    [Show full text]
  • (320) Nhdot 14350 Alternative Mitigation Report
    STRAFFORD SQUARE INTERSECTION IMPROVEMENTS ROCHESTER X-A000 (320) NHDOT 14350 ALTERNATIVE MITIGATION REPORT THE WENTWORTH HOMESTEAD (27-ST-113) ROCHESTER (STRAFFORD COUNTY), NEW HAMPSHIRE Prepared by Ellen Marlatt, MA, RPA, Jessica Cofelice, MA, RPA and Kathleen Wheeler, PhD, RPA, www.iac-llc.net IAC #1303 FINAL REPORT March 26, 2018 TABLE OF CONTENTS LIST OF FIGURES ................................................................................................................................... II LIST OF TABLES ................................................................................................................................... III LIST OF PLATES ................................................................................................................................... III CHAPTER ONE: INTRODUCTION ....................................................................................................... 1 CHAPTER TWO: CULTURAL CONTEXT FOR THE STUDY.......................................................... 5 Competing Theories of Health and Wellness ....................................................................................... 5 New Hampshire Medical Society ......................................................................................................... 6 Medical Education and Training ........................................................................................................ 7 Pharmacies and Patent Medicines ........................................................................................................
    [Show full text]
  • A Guide to Pharmacy Museums and Historical Collections in the United States and Canada by George Griffenhagen, Ernst W
    A Guide to Pharmacy Museums and Historical Collections in the United States and Canada by George Griffenhagen, Ernst W. Stieb, Beth D. Fisher (American Institute of the History of Pharmacy, 1999) ALABAMA_________________________________ Birmingham Alabama Museum of Health Science Lister Hill Library of the Health Sciences University of Alabama at Birmingham 1700 University Boulevard University Station, AL 35294-0013 (205) 934-4475 Managed by the University of Alabama at Birmingham. Michael Flannery, executive director. Monday - Friday 8:00 a.m. - 5:00 p.m. Admission - free A large hall includes exhibitions on pharmaceutical tools, drug bottles, medical and dental equipment, nursing and ophthalmological artifacts, together with documents, photographs, memorabilia, and archival material related to the health professions in the state of Alabama. In an adjacent hall is the Lawrence Reynolds Historical Library, which includes rare books and archives. *** Jacksonville Dr. J. C. Francis Medical Museum 100 Gayle Street Jacksonville, AL 36265 (256) 435-7611, ext. 8 Managed by the State of Alabama Historical Commission, 468 S. Perry Street, Montgomery, AL 36130-0900, (334) 242-3184 ext. 248. Open by appointment only. Admission - free The museum and grounds are owned by the Alabama State Historical Commission. The museum was opened to the public on March 21, 1974, when a marker in memory of Dr. J.C. Francis was unveiled by his great- grandson. The restored structure consists of two rooms, an apothecary shop in front leading into a physician’s office in the rear. The building was constructed about 1850 and was occupied by Dr. Francis for almost forty of his fifty-four years of practice as a family physician in Jacksonville.
    [Show full text]
  • Pharmaceutical Manufacturing in America: a Brief History
    Pharmaceutical Manufacturing in America: A Brief History by Arthur Daemmrich* Abstract: This article reviews the history of drug manufacturing and changes in the compounding of drugs by pharmacies in the United States and outlines opportunities for new research into the making of medicines. The pharmaceutical indus- try has long been on the vanguard of globalization, and drug companies restructured their international manufacturing footprints frequently in the 19th and 20th centuries. Firms in the prescription drug sector were among the first to market products internationally, to build manufacturing plants around the world, and to integrate research from laboratories across multiple time zones. Yet, issues of quality and safety have arisen repeatedly and the industry has continued to pro- duce its newest medicines in North America even as technological capabilities increased significantly in China, India, and elsewhere since the 1980s. Compounding pharmacies, by contrast, experienced a steady decline during the second half of the 20th century as medicines arrived from producers in final form. The emergence of individualized therapies, however, is now bringing a resurgence in business for biological labs acting in many ways as compounders. Broadly, as pharma- ceutical firms turned to a business model built around research and intellectual property production, and as pharmacists shifted from producing medicines to repackaging them for patients, analysts likewise turned to regulation, pricing, and new product innovation as subjects of their research. As a consequence, pharmaceutical manufacturing is largely ignored in the recent historiography of medicine, pharmacy, and pharmaceuticals, an oversight that should be rectified. Introduction countries, while biotech-based medicines were produced in the United States and Europe.
    [Show full text]