DarshanTalks Podcast Darshan Kulkarni

Buying a Drug or Device Company? 6 Compliance Must-KnowsThinking of acquiring a drug or device company? Buckle up! This deal requires serious compliance considerations. Here's a quick rundown:The DOJ offers a 6-month "safe harbor" for confessing past compliance issues. Use it!The DOJ demands strong compliance programs with thorough risk assessments, effective training, and clear reporting channels.Companies can now claw back bonuses from employees who break compliance rules.Accurate risk asse...

We discuss how recent shortages of chemotherapy drugs like cisplatin and carboplatin have caused delays and changes in treatment plans for some cancer patients. While the situation is improving, shortages still exist for some drugs. Staying informed is crucial, and the FDA is actively tracking drug shortages to mitigate them. It's important to communicate with your doctor, who can provide the latest information and discuss alternative treatment options tailored to your needs.

We discuss how failure to register with the appropriate state boards of Pharmacy as a drug or device manufacturer can lead to severe consequences. These consequences include1. Hefty fines, revoked licenses, and even legal charges, potentially ruining your business. 2. Additionally, non-compliance can result in reputational damage, eroding public trust and deterring potential partners. 3. Moreover, loss of distribution rights could leave you unable to serve customers in entire states...

We discuss six critical errors in the informed consent process:1. Exclusion of Principal Investigator: PI was not allowed to engage in the informed consent process.2. Lack of Detailed Discussion: Staff members did not take the time to thoroughly discuss the study's potential benefits and risks with prospective subjects.3. Inadequate Training: Coordinators lacked knowledge about the study and lacked a research background, leading to insufficient information provided to participants.4. Unauthor...

Informed consent is a crucial aspect of clinical trials, ensuring that prospective subjects understand the benefits, risks, and potential harms of participating in a study. This process involves full disclosure of information, allowing subjects to ask questions and address concerns with a knowledgeable medical professional. For minors, parental involvement is required, and subjects have the right to withdraw consent at any time. It's not merely a form but an ongoing process that starts b...

In this podcast, we discuss the following: Recent updates from the courts in class action lawsuits. Difference between equity and law. Demerging or diverging equity and law. Dictionaries used by courts to interpret contracts. Update on Johnson and Johnson baby powder case (Suing plaintiff’s witnesses for defamation and false advertising) Experts need to be cautious to avoid false advertising allegations against them. Update on Maybelline 24-hour make-up case...