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A Regulatory Lawyer's Perspective: The FDA's Guidances on Risk Assessment, Minimization and Management
In the pharmaceutical industry, due to all types of business pressures and constraints, it is not atypical for a company to behave reactively and in triage-mode, rather than considering proactive steps that it can take in the compliance arena. In 2005, the Food and Drug Administration (“FDA”) issued three final guidance documents to help focus the industry and encourage companies to consider more thoughtfully and thoroughly the issues of quality risk assessment, minimization, and management collectively.
Background
The guidances are not law. They do not bind the FDA or the industry. However, the guidances reflect the agency's current thinking, and it would be foolish not to review the FDA's playbook. At a minimum, they should be considered best industry practices.
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Major Differences In UK, U.S. Copyright Laws
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Strategy vs. Tactics: Two Sides of a Difficult Coin
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.
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Removing Restrictive Covenants In New York
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?