FDA seeks safer drugs and biologics

被引：0
|
作者：
Wechsler, Jill [1 ]
机构：
[1] Biopharm, Chevy Chase, MD 20815 USA
来源：
BIOPHARM INTERNATIONAL | 2007年 / 20卷 / 03期
关键词：
D O I：
暂无
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
引用
收藏
页码：24 / +
页数：2
相关论文
共 50 条
  • [41] Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics
    Janda, Guneet S.
    Wallach, Joshua D.
    Dhodapkar, Meera M.
    Ramachandran, Reshma
    Ross, Joseph S.
    JAMA INTERNAL MEDICINE, 2023, 183 (11) : 1271 - 1273
  • [42] New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics
    Zachary Smith
    Emily Botto
    Otis Johnson
    Todd Rudo
    Kenneth Getz
    Therapeutic Innovation & Regulatory Science, 2024, 58 : 143 - 152
  • [43] New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics
    Smith, Zachary
    Botto, Emily
    Johnson, Otis
    Rudo, Todd
    Getz, Kenneth
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2024, 58 (01) : 143 - 152
  • [44] Challenges and approaches for the development of safer immunomodulatory biologics
    Sathish, Jean G.
    Sethu, Swaminathan
    Bielsky, Marie-Christine
    de Haan, Lolke
    French, Neil S.
    Govindappa, Karthik
    Green, James
    Griffiths, Christopher E. M.
    Holgate, Stephen
    Jones, David
    Kimber, Ian
    Moggs, Jonathan
    Naisbitt, Dean J.
    Pirmohamed, Munir
    Reichmann, Gabriele
    Sims, Jennifer
    Subramanyam, Meena
    Todd, Marque D.
    Van der Laan, Jan Willem
    Weaver, Richard J.
    Park, B. Kevin
    NATURE REVIEWS DRUG DISCOVERY, 2013, 12 (04) : 306 - 324
  • [45] Challenges and approaches for the development of safer immunomodulatory biologics
    Jean G. Sathish
    Swaminathan Sethu
    Marie-Christine Bielsky
    Lolke de Haan
    Neil S. French
    Karthik Govindappa
    James Green
    Christopher E. M. Griffiths
    Stephen Holgate
    David Jones
    Ian Kimber
    Jonathan Moggs
    Dean J. Naisbitt
    Munir Pirmohamed
    Gabriele Reichmann
    Jennifer Sims
    Meena Subramanyam
    Marque D. Todd
    Jan Willem Van Der Laan
    Richard J. Weaver
    B. Kevin Park
    Nature Reviews Drug Discovery, 2013, 12 : 306 - 324
  • [46] FDA approves safer form of terfenadine
    Barnett, AA
    LANCET, 1996, 348 (9024): : 395 - 395
  • [47] FDA seeks comments on flexible labeling guidance
    不详
    JOURNAL OF THE AMERICAN VETERINARY MEDICAL ASSOCIATION, 1998, 212 (06) : 789 - 789
  • [48] Harmonizing biologics and drugs
    Wechsler, J
    BIOPHARM-THE APPLIED TECHNOLOGIES OF BIOPHARMACEUTICAL DEVELOPMENT, 1998, 11 (10): : 16 - +
  • [49] An open letter to the FDA regarding changes in reporting procedures for drugs and biologics proposed in the wake of the FIAU tragedy
    Meinert, CL
    CONTROLLED CLINICAL TRIALS, 1996, 17 (04): : 273 - 284
  • [50] FDA seeks input on unapproved drug issue
    Snelson, Harry
    JOURNAL OF SWINE HEALTH AND PRODUCTION, 2011, 19 (04): : 249 - 249
12345