According to FDA 820.3(z), “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

Medical journals and textbooks are clear that the only way to accurately determine the life-or-death impacts of medical treatments is by measuring “all-cause mortality” in “randomized controlled ...

In the final written decision of an inter partes review, the Patent Trial and Appeal Board (PTAB) found all claims at issue unpatentable, concluding that the prior art provided strong evidence of ...

We have seen an almost 10 times increase in COVID-19 cases in the last week or so. Why are we seeing this significant increase? What in our behavior has changed? Everywhere I go, people wear masks and ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective indicia of ...

Cannabis constituent cannabinol increases sleep, as per a new study. Scientists at the University of Sydney have provided the first objective evidence that cannabinol (CBN) - a constituent of cannabis ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...