1. Home
  2. |Insights
  3. |Thompson Interactive - 15 Days Until Enforcement: Responding to 483s and Warning Letters from the New FDA

Thompson Interactive - 15 Days Until Enforcement: Responding to 483s and Warning Letters from the New FDA

Event | 10.06.09, 12:00 AM UTC - 12:00 AM UTC

Your company has just been issued a 483. When you respond, and what you say in your response, can reduce the risk of a warning letter. Or perhaps your company’s response to a 483 was not satisfactory to the FDA, and now you do have a warning letter. What now?

In this 90-minute audio conference, former FDA deputy associate commissioner for Regulatory Operations Steve Niedelman and attorney Cathy Burgess will discuss what you must do, from the time the investigator signs her name until the FDA indicates “no further action is necessary.”

For more information, please visit these areas: Product Risk Management

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.