Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Limiting Access to Investigational Drugs
The U.S. Court of Appeals for the District of Columbia in March began reconsideration of its decision that held it was unconstitutional for the Food and Drug Administration (FDA) to withhold experimental drugs from terminally ill patients. The original decision, in Abigail Alliance for Better Access to Developmental Drugs v von Eschenbach, 445 F.3d 470 (D.C.Cir.2006), challenging the FDA's policy against permitting anyone to take unapproved drugs outside the normal channels, such as the clinical study setting, was decided by a three-judge panel of the court last May. The order for rehearing en banc was issued in November 2006. The case pits dying, often desperate, patients against the FDA and its policies aimed at protecting the public from dangerous and unproven medications.
The Plaintiffs
The Abigail Alliance was incorporated in 2001 as a group dedicated to bringing as-yet unapproved drugs to the terminally ill. It was named in honor of a woman who had died of cancer at the age of 21, after she was unsuccessful in her efforts to become a subject in tests for two drugs that were still in the experimental stage. Although Abigail was accepted into the clinical trial of a third promising drug, it was too late to save her. Her family, other gravely ill patients and their families and other interested parties formed the Abigail Alliance to advocate for access to experimental drugs by people who are mentally competent but terminally ill.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.