Trade Secrets Theft In Life Sciences

Examples of Trade Secrets In Life Sciences The term trade secret refers to intellectual property—including but not limited to an idea, pattern, formula, or process—that is kept secret by the owner of that information to prevent its theft or misuse. Examples of trade secrets in the life sciences include drug compounds, formulations, routes of synthesis, […]

FDA’s 505(b)(2) Application

The 505(b)(2) new drug application (NDA) is an attractive regulatory and commercial strategy for clients. This hybrid NDA application helps avoid duplicative and costly studies that others have already completed. FDA’s rules allow (b)(2) applicants to rely on this prior body of work. And because of this reliance, the (b)(2) development is cheaper and faster […]