Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's (“FDA's”) failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs (“NAIDs”). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, ie, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.
For marketed drug products, the FDA has traditionally acted unilaterally when the risk/benefit calculation for drug approval has been undermined. Today, as the agency's credibility in protecting the public is coming under repeated attack, the advisory committee meeting is providing a variant approach that is another step in the growing importance of advisory committees at the FDA. The advisory committee process increases the transparency of the scientific debate, and the openness demystifies the process. Passions are tempered. The process forces a dialogue on the known facts, and it exposes the voids of data. Transparency stabilizes the process. Nevertheless, the advisory committee meeting remains only one element in the decision-making process. Because the FDA remains legally responsible, it controls that process, including the timing of the meetings, the preparation of briefing documents, and the ultimate decision.
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
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
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.