FDA Regulations Relating to Good Clinical Practice and Clinical Trials

FDA has set up website with links to all FDA regulations related to Good Clinical Practices and Clinical Trials. The site has also a link to preambles to GCP regulations with valuable information about the development of final rules for Good Clinical Practices and clinical trials.

Source:FDA

2 Responses to FDA Regulations Relating to Good Clinical Practice and Clinical Trials

  1. Michael Falkow says:

    What regulatory citation requires SAEs experienced in clinical studies outside US (but supporting US IND and/or distribution) be reported to FDA?
    Thanks; I need this info to change opinion.

  2. My fellow on Orkut shared this link and I’m not dissapointed that I came to your blog.

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