Practice Tip: FDA Issues Draft Guidance for REMS
The first part of this article discussed the background of REMS (Risk Evaluation and Mitigation Strategies) and provided a summary of the Draft Guidance. The conclusion herein explains the second part of the procedure, including proposed modifications and communicating with the FDA.
When Attorneys Ghostwrite Experts' Reports
How much attorney involvement in the drafting of experts' reports is permissible? Must the entire work product be that of the expert? Or, at the other extreme, would it be acceptable for an attorney to draft the entire expert's report with the expert "adopting" it?
Active Inducement In the Post-Grokster World
This article discusses the theory of active inducement in copyright law, the evolution of P2P technology over the past decade, recent U.S. and foreign legal decisions, and developments impacting copyright holders, file-sharing networks and Internet service providers.
The Virtual Company
Entrepreneurs have always chafed against the formalities and procedures demanded of them by their attorneys and, more generally, by business laws. Who hasn't had to keep reminding clients of the importance of signing and returning annual minutes ' again and again and again? This is even more so for the tech sector, and e-commerce founders. After all, they created an industry by thinking outside the proverbial "box," so why should their creativity be constrained by legal rules created for the age of the steam engine?
Blogging and Your Business
As a marketer, know that if your employees post a blog comment, or an entry on Facebook or Twitter about your company or its products, a number of questions are raised. Is your company responsible for what is said?
Blogging and Your Business
As in-house counsel, if your employees post a blog comment, or an entry on Facebook or Twitter about your company or its products, a number of questions are raised. Is the company responsible?
