Risky Business: New Compliance Challenges for FDA-Regulated Industry
Event | 05.19.10, 12:00 AM UTC - 12:00 AM UTC
The FDA's Enforcement Initiative has created new challenges for regulated businesses. The agency is devoting significantly more resources to conducting inspections, with an increased emphasis on global supply chain quality. Moreover, the FDA is responding more rapidly and more aggressively to inspectional findings, placing greater importance on timely responses. In the past, firms with compliance problems often had ample time to implement corrective actions before the agency took enforcement action. Now, failure to respond to inspectional findings within fifteen days could trigger a Warning Letter or other significant enforcement action.
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Insights
Event | 02.20.25
Has the Buss Stopped? Recoupment Today
Has the Buss Stopped? Recoupment Today: In 1997, the California Supreme Court decided Buss v. Superior Court. In Buss, the court concluded that a liability insurer that defended a mixed action could seek reimbursement from the insured for the defense costs associated with the claims that were not even potentially covered. Since then, numerous courts have held that insurers are entitled to recoup their defense costs associated with uncovered claims or causes of action. On the other hand, a significant number of courts have rejected insurers’ right to recoupment, at least in the absence of a policy provision granting the insurer that right. Some commentators have even suggested that the current judicial trend might be away from permitting insurers to recoup their defense costs. Is that correct? Has the Buss stopped? This panel of coverage experts will analyze insurers’ claimed right to recoupment today, and offer their perspectives on what the law on recoupment should perhaps be and might be in the future.
Event | 12.05.24
Event | 12.05.24
Event | 12.04.24
Inside the Arbitrators’ Chambers: Best Practices of Arbitrators