Mitchel J T
Target Health Inc, New York, NY, USA.
Dialogues Clin Neurosci. 2000 Sep;2(3):213-7. doi: 10.31887/DCNS.2000.2.3/jtmitchel.
Working closely and cooperatively with regulatory authorities during drug development is vital to successful drug development programs. In the United States, the drug development team includes not only members of the key disciplines of drug discovery, clinical research, regulatory affairs, marketing, chemistry, toxicology, and legal aspects, but also the Food and Drug Administration (FDA). New regulations encourage meetings at the pre-investigational new drug (pre-IND), end-of-phase-2, and pre-new drug application (pre-NDA) submission phases. Appropriate informal discussions via fax and telephone are also encouraged. By proactively interacting with the FDA, the pharmaceutical industry increases the probability of a successful drug development program.
在药物研发过程中与监管机构紧密合作对于成功的药物研发项目至关重要。在美国，药物研发团队不仅包括药物发现、临床研究、监管事务、市场营销、化学、毒理学和法律等关键学科的成员，还包括食品药品监督管理局（FDA）。新法规鼓励在研究性新药申请前（IND前）、2期结束时以及新药申请前（NDA前）提交阶段举行会议。同时也鼓励通过传真和电话进行适当的非正式讨论。通过与FDA积极互动，制药行业提高了药物研发项目成功的概率。
