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The FDA's New Guidance on Data Integrity
The Food and Drug Administration (FDA) recently released a draft guidance for industry, “Data Integrity and Compliance with CGMP” (Current Good Manufacturing Practices). See http://1.usa.gov/25IzpM4. While the draft is not legally binding on industry or the agency, it offers the FDA's current thinking on how drug and biologic manufacturers can comply with current Good Manufacturing Practices, to ensure completeness, consistency, and accuracy of data. In recent years, FDA has taken numerous enforcement actions against companies for data integrity-related violations during GMP inspections. In addition to describing the agency's expectations, the document also offers companies a means to reduce potential product liability exposure.
This article highlights some of the key points in the guidance and attempts to identify the agency's central concerns and recommendations.
Key Definitions
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Major Differences In UK, U.S. Copyright Laws
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.
The Article 8 Opt In
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.
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.
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?
The Benefits of Blockchain for e-Discovery and Data Preservation
As businesses across various industries increasingly adopt blockchain, it will become a critical source of discoverable electronically stored information. The potential benefits of blockchain for e-discovery and data preservation are substantial, making it an area of growing interest and importance.