ARTICLES BY DARSHAN KULKARNI
Sponsors must proactively mitigate Sunshine Act compliance risks by conducting thorough internal audits, reevaluating policies and procedures, and ensuring all financial interactions with healthcare providers align with legal and ethical standards.
The Office of Research Integrity (ORI) has proposed updates to the Public Health Service Policies on research misconduct. Darshan Kulkarni outlines how the new proposals should influence sponsors to reevaluate their existing clinical trial practices and policies.
In March 2023, the criminal division of the U.S. Department of Justice (DOJ) updated its Evaluation of Corporate Compliance Programs document to serve as a guide for prosecutors in assessing the effectiveness of a company's compliance program.
Syneos Health made headlines when it announced it may soon be acquired by a private equity consortium for approximately $7.1 billion. This transaction represents an exciting opportunity for both parties, but it also underscores the importance of thorough due diligence to ensure that the acquiring party maximizes value from the target entity.
While there is a lack of specific guidance on sharing risk communications via social media, it may be possible to enhance the safety of biopharmaceuticals by using timely and measurable social media communications without violating FDA guidelines or regulations.