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On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required...
Exhibit 99.1 Risk Factors The following risk factors should be carefully considered together with all of the other information in our annual and quarterly... | October 21, 2021
On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill...
Single IRB review for multicenter research is now the norm in the US. Initiatives that are requiring harmonization between the FDA regulations and...
Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as "right-to-try." Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures.