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Drug & Device News
Another Step Taken Toward Approval of Silicone Breast Implant Sales
The FDA in September issued an approvable letter to Inamed Corp. for its premarket application (PMA) for silicone gel-filled breast implants. An approvable letter is one of several intermediate steps in the FDA review process of new products but it does not mean that Inamed's device is yet approved by the agency. Previously, at its April 2005 meeting, the FDA's General and Plastic Surgery Devices Advisory Panel recommended by a vote of 5 to 4 not to approve Inamed's PMA. Since then, Inamed has provided the FDA with additional information to address the primary safety concerns discussed by the panel. Inamed has also said that it will no longer make available its Style 153 device, which had raised particular safety issues for the panel.
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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
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.
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.
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.