Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
In order to minimize potential product liability associated with pharmaceutical products, companies regulated by the U.S. Food and Drug Administration ('FDA') should be vigilant in ensuring that adverse drug experiences ('ADEs') are reported to the FDA in a timely and complete manner. FDA regulations contain extensive requirements regarding the reporting of ADEs for companies involved in the distribution chain, such as manufacturers and distributors. Failure to report, when required, can result in an FDA enforcement action and exacerbate liability exposure. A proactive ADE collection and reporting system will place a company in a better position to address unanticipated issues that may arise after full-scale commercial marketing has begun. Therefore, companies must know their regulatory responsibilities and implement procedures to ensure that ADEs are collected and reported, as required by law. This article covers only some of the re-quirements and issues to consider.
Regulatory Overview
What Types of Events Require Reporting?
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
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?