DarshanTalks Podcast Darshan Kulkarni

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 include

1. 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.

 To avoid this nightmare scenario, ensure registration with state boards of Pharmacy. For
 assistance, contact us at Darshan@kulkarnilawfirm.com

Have you ever wondered why your prescription takes what feels like an eternity to fill at the pharmacy? Darshan will shed some light on the process. 

When you drop off your prescription, the pharmacist isn't just mindlessly grabbing bottles from shelves. They're meticulously reviewing your medication to ensure it's the right fit for your condition, checking for potential interactions with other drugs or even your diet, and making sure it's covered by your insurance.

This detailed process, while aided by computer systems, often requires a human touch and can take some time. And remember, you're not the only one waiting for their medication – there's a queue of patients with prescriptions to fill.

So next time you're twiddling your thumbs in the pharmacy waiting area, remember that your pharmacist is doing their best to ensure your health and safety.

 

We cover three steps for preventing food recalls:
Identify all potential hazards.
Focus on known and foreseeable risks.
Develop preventive controls for specific hazards.
Ensure every bite is safe! Need help? Call Darshan at 302.252.6959.

In this video, Darshan distinguishes between dietary supplements and drugs. The 
primary difference lies in the claims they can make. Dietary supplements are treated as foods and can only make limited claims, such as improving health or well-being. In contrast, drugs undergo rigorous FDA approvals and trials to make claims of curing, treating, preventing, or mitigating diseases. While there may not be much difference chemically, the key distinction is in the level of proof required for their claims. Darshan highlights that drugs may have once been dietary supplements but must meet higher evidentiary standards. 

Here are 5 clinical trial record retention problems.
1. Fabricating Data and Documentation,
2. Forging the Principal Investigator's signatures,
3. Data Manipulation,
4. Misappropriating Samples and 
5. Forging Subject Dairies

Join us as we delve into the complexities of record retention and data integrity in clinical trials. Learn why compliance is key for FDA approval and how we can help. Call us at 302-252-6959 for expert assistance with your clinical trial compliance program.

Bringing a drug to market is a costly and intricate process, averaging $2.3 billion. This expense encompasses multiple levels of testing, ranging from small animals to extensive human trials. The drug company, whether partnering with a university or a private investor, foots the bill for each phase of testing, ensuring safety and efficacy before reaching the market. The investment covers meticulous testing procedures, safeguarding against potential risks and ensuring the drug's viability on a large scale.