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Practice Tip: The Physician Labeling Rule
On June 30, 2006, new regulations governing the format and content of prescription drug labels went into effect. These changes marked the first major overhaul of drug labeling rules in more than 25 years.
The primary purpose of the changes is to make labels more accessible to practicing physicians. When the FDA first issued the rule in December 2000, it expressed concern that product labels had become too cluttered as a result of growing chemical complexity of drugs and the effects of product liability litigation. The new label, including a 'highlights' section, a table of contents, and a streamlined adverse reaction section, is designed to return the product label to its originally intended purpose as a useful and clear tool for practicing physicians.
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The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
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New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.