RAPS

FDA aims to speed gene therapy development with prior scientific knowledge guidance

The US Food and Drug Administration (FDA) has proposed guidance on the types of scientifically valid prior knowledge sponsors should consider when developing certain gene therapies (GT). The agency ...
PharmTech

Using Prior Knowledge in Biotechnology Testing

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production. Efforts to streamline the development of new medicines, particularly breakthrough therapies, are focusing ...
The National Law Review

“Prior Knowledge” Claims and How to Avoid Them

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 ...
JD Supra

Prior Knowledge and Prior Notice Exclusions Barred Coverage For Legal Malpractice Claim

The United States District Court for the District of North Dakota has held that an insurer had no duty to defend a claim under a lawyers professional liability policy where the insured had prior ...
The National Law Review

Buyer Beware: Analyzing New Jersey Court’s Ruling on Prior Knowledge Exclusions

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 ...