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When Is Compliance Necessary?
The pharmaceutical industry has been heavily regulated for many years, starting with the original enactment of the Food and Drug Act in 1906. Over the years, a bewildering array of regulations has been established that affect the sale and consumption of drugs at both the federal and state levels. While many of these past regulations have been subsumed into the FDA's rules and regulations, one of the most difficult and currently pressing questions a pharmaceutical manufacturer must ask itself is whether to comply with California's Proposition 65. The manufacturer's decision to comply may have significant adverse affects on marketing and use of the drug; or conversely, imposition of stiff, costly penalties. This article provides a basic roadmap of the current landscape for compliance with Proposition 65 in the pharmaceutical context.
Background
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.
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.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.