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 ...

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...

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 ...

Harm and the potential for harm from medical care is pervasive and well-documented. Much of the safety literature has historically focused on physical harm, but the Agency for Healthcare Research and ...

A growing trend in medical device litigation is the claim that defendant manufacturers are liable for failing to report adverse events to the Food and Drug Administration (FDA). Unlike a standard ...