五月天堂婷婷爱,色狠狠天天综合色香阁,91免费看国产,久久久久成人精品亚洲国产av综合,91啦在线播放,免费a一级毛片在线播放,天天日日夜夜看综合网,亚洲成人国产精品,奇米影视7777狠狠狠狠色,日韩精品高清在线观看,福利久久久,久久99国产精品片久久99蜜桃,91香蕉视频网址,婷婷91,久久久久久臀欲欧美日韩,少妇丰满大乳被男人揉捏视频

What Are the Regulatory Authorities for Clinical Trial Reports in the United States?
Category：行業(yè)資訊 Date：2024-09-03 17:26:07 Author: Source:
These authorities ensure that clinical trials are conducted according to regulatory standards and that the results are thoroughly reviewed and reported

In the United States, the primary regulatory authorities for Clinical Trial Reports are:7(1).jpg

1. Food and Drug Administration (FDA)

  • Role: The FDA is the main regulatory body overseeing clinical trials for drugs, biologics, and medical devices. It reviews Clinical Trial Reports as part of the New Drug Application (NDA), Biologics License Application (BLA), or Premarket Approval (PMA) process.
  • Website: FDA

2. Institutional Review Boards (IRBs)

  • Role: IRBs review and approve clinical trial protocols and ensure that trials are conducted ethically and that participants' rights are protected. They are not regulatory bodies but play a crucial role in the oversight of clinical trials.
  • Website: Office for Human Research Protections (OHRP)

3. National Institutes of Health (NIH)

  • Role: While not a regulatory body, the NIH supports and funds clinical trials and requires the submission of trial results and reports for its funded studies. It also maintains the ClinicalTrials.gov registry, where trial results are often posted.
  • Website: NIH

4. Centers for Medicare & Medicaid Services (CMS)

  • Role: For trials involving medical devices or interventions covered by Medicare or Medicaid, CMS may be involved in evaluating the effectiveness and outcomes of these interventions.
  • Website: CMS

These authorities ensure that clinical trials are conducted according to regulatory standards and that the results are thoroughly reviewed and reported

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn