ACI - The Legal, Regulatory & Compliance Forum on OTC Drugs
Event | 10.17.12 - 10.19.12, 12:00 AM UTC - 12:00 AM UTC
FDA's proposed introduction of a new paradigm for 'OTC drugs with conditions of safe use' (which some industry observers have referred to as a third class of drug product or 'behind the counter'/ 'BTC' products ) will put a new twist on existing legal and regulatory protocols and product commercialization in the OTC space. Self-diagnosis and self-care, two basic tenants of the current OTC paradigm may be supplemented with the assistance of a pharmacist and rapid diagnosis testing, thus leading to a multitude of questions ranging from scope of FDA authority to potential liabilities.
To help make sense of this new proposal and its potential impact on existing legal and regulatory structures in the OTC environment, ACI has developed The Legal, Regulatory and Compliance Forum on Over the Counter Drugs. A distinguished faculty of over two dozen leading legal and regulatory OTC experts --- including FDA representatives --- will address the intricacies of this new proposal as well as existing challenges affecting such core OTC functions as advertising and promotion; labeling; trademarks, trade names and line extensions; and the modernization of the monograph system.
Dick Downing is scheduled to speak on October 18th on the topic of "Making and Maintaining Your Mark: Mitigating Legal and Regulatory Risks Relative to Trademarks, Trade Names and Brand Name Product Line Extensions in the OTC Space."
For more information, please visit these areas: Intellectual Property, Intellectual Property Litigation
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
