Practice Tip: FDA Issues Draft Guidance for REMS
February 25, 2010
On Sept. 30, 2009, the FDA issued a draft guidance for industry on better understanding and implementing Risk Evaluation and Mitigation Strategies (REMS), which the FDA requires for certain drugs or biologics.
CPSC Poised to Implement Online Product Hazard Database
February 25, 2010
The CPSC is posed to unveil its own online reporting system and public database of actual and potential product hazards. Unless the CPSC implements adequate safeguards, information disseminated through the new online database may be wholly unverified.
Alternative Fees
February 25, 2010
The desire among senior corporate counsel and management to control costs has pushed consideration of alternative fee arrangements (AFAs) to the forefront. Some estimates suggest that within five years, as much as half the Am Law 200 revenue might come from AFAs.
Heightened FCPA Exposure for Executives
February 25, 2010
In enforcement of the Foreign Corrupt Practices Act (FCPA), the standards are continuously evolving, leaving corporate executives increasingly preoccupied with how prosecutors and regulators might view their activities. Some executives say this issue keeps them up at night.
Feds to Corporate America: 'The Cops Are Coming'
February 25, 2010
On Jan. 19, the Department of Justice (DOJ) announced the arrest of 22 individuals as part of a "sting" operation aimed at uncovering violations of the Foreign Corrupt Practices Act (FCPA). As intended, the case got a great deal of publicity due to both the large number of individuals arrested and the manner in which the investigation was handled.
Web Searches As a Litigation Tool
February 24, 2010
In any lawsuit, the collection of information on a party or witness is of paramount importance. What seems to someone like innocuous information ' such as photographs of vacations and daily activities and postings to special interest Web sites ' can materially affect the outcome of a case.
Alternative Fees
February 24, 2010
The diversity of AFA approaches and objectives can divide consumers and providers of legal services, and magnify the law firm-client communication challenges presented by movement away from an entrenched business model.
Going Out on Your Own?
February 24, 2010
The economic turmoil of the past two years has had a dramatic impact on those of us who chose a career in the private practice of law. For many attorneys, these conditions have created an ideal time to strike out on their own and fulfill a dream of becoming a solo practitioner. For others, substantial layoffs at large firms and hiring freezes throughout the legal profession have teamed up to leave them with no other choice but to make a go of hanging out their own shingle.
e-Getting Your Back
January 28, 2010
Science tells us that most of an iceberg is hidden beneath the surface of the ocean. e-Commerce law tells us the same thing about Web-site development: The "Web front" that shoppers see can be dwarfed by the hidden, or invisible, "back office" ' the contracts, negotiations and software that make e-commerce Web sites possible. Yet it is that back office that can be the difference between a profitable site and one, like a true iceberg, that is merely adrift and fraught with potential hazards.
