The New York State Department of Health offers a free, downloadable adverse event reporting form for office-based surgery. The four-page form includes sections detailing accreditation, the nature of ...
Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the ...
The FDA recently launched a new Adverse Event Reporting System exclusively for cosmetic products, part of a larger agency effort to promote greater transparency for consumers, the agency announced in ...
Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
When the HSRO approves human-subjects research, the approval is based upon the information about how the research will be conducted and the risks and anticipated benefits to subjects that are known at ...
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