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carpal    音标拼音: [k'ɑrpəl]
a. 腕骨的
n. 腕骨

腕骨的腕骨

carpal
adj 1: of or relating to the wrist; "Carpal tunnel syndrome"
n 1: any of the eight small bones of the wrist of primates [synonym:
{carpal bone}, {carpal}, {wrist bone}]


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英文字典中文字典相关资料:


  • eCFR :: 21 CFR 812. 35 -- Supplemental applications.
    Except as described in paragraphs (a) (2) through (a) (4) of this section, a sponsor must obtain approval of a supplemental application under § 812 30 (a), and IRB approval when appropriate (see §§ 56 110 and 56 111 of this chapter), prior to implementing a change to an investigational plan
  • IDE Maintenance | Clinical Center
    Most changes to the investigation, including the protocol, the clinical site or principal investigator, or the manufacturing process, must be sent to the FDA prior to enacting the change However, FDA approval may be required depending on the change More information is detailed below
  • Regulatory Guidance for Academic Research of Drugs and Devices - ReGARDD
    All IDE submissions should be sent to the person identified by the FDA in your initial notification letter Although there is not a standard format for progress reports, specific topics need to be addressed so the FDA can evaluate the investigation effectively
  • Investigational Device Exemption (IDE) | FDA
    All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated
  • What is the difference between IDE amendment and supplement?
    Understanding the key difference between IDE amendment and supplement is crucial for regulatory compliance Learn when to submit each for FDA-regulated medical device clinical trials
  • Maintaining your IDE | Office of Ethics and Compliance
    IDE reports are now tracked as a report and not as a supplement For IDE reports, the FDA will respond to the sponsor-investigator within 30 days if the FDA has questions or requests for additional information; otherwise, the FDA may close the submission without issuing a formal response
  • IND IDE Support FAQs - University of Pittsburgh
    For an IDE, is there a wait time to implement protocol changes after IRB approval and the IDE Supplement has been submitted to the FDA? Yes, the Sponsor must wait for FDA approval of the Supplement before implementing protocol changes
  • Maintaining your Investigational Device Exemption (IDE) with the FDA . . .
    An investigator must never forget that an IDE application is a “living” project that must be constantly monitored, updated, and nurtured from approval to closure to maintain compliance
  • IDE GENERAL INSTRUCTIONS – PROTOCOL AND INFORMATION AMENDMENTS
    The FDA tracks requests for a new protocol, changes to the approved protocol, or changes to the device, such as device design or manufacturing change, as supplements
  • IDE Application | FDA
    Once the IDE is approved, the sponsor may submit an IDE supplement to request approval of additional clinical study sites FDA will respond in writing to the supplement approving or





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