Traditional mediation today is often led by mediators who are not formally trained in the art of negotiation. As a result, their version of “mediating” is simply “splitting the pie”, often leaving both parties dissatisfied.
In the second part of the clinical trials series, we examine the duties and obligations of Sponsors and Clinical Research Organizations (CRO) as it relates to the protection of human subjects who participate in clinical trials.
In the selection of a Clinical Research Organization (CRO), the Sponsor must ensure that the CRO has careful policies and procedures in place to safeguard protected patient information.
FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements.
FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real time Oncology Review (RTOR).
When does “Puffery” constitute Investor-Fraud?For many companies seeking to raise capital, an important 9th circuit case is illustrative of what exactly constitutes actionable puffery, which would generally constitute a false and misleading material statement to...
It is a common presumption that when a business owner incorporates their company or registers it as an LLC, they become protected from being held personally liable for any debts incurred by the business. Although this may be true to a certain extent, it does not...
While employers generally understand that they owe a duty to maintain the safety of their employees while those employees are in the scope of their employment, can an employer be responsible for the health, welfare and safety of an employee’s family? As a result of...
The right to copyright protection is outlined in the U.S. Constitution to protect the rights of those who produce content; however also embedded in the Constitution is the idea that the “progress of science and useful arts” must be promoted. U.S. Const. Art. I, § 8,...
1. SEC’s Proposed Rule Regarding Cybersecurity Breach Notifications On March 9, 2022, the United States Securities and Exchange Commission (“SEC”) has proposed a rule requiring publicly traded company to disclose “material” cybersecurity breaches within 4 days of the...