Does the FDA Have Jurisdiction Over Stem Cell Clinics?

Does the FDA Have Jurisdiction Over Stem Cell Clinics?

Stem cell clinics have come under scrutiny from the Food and Drug Administration (FDA) for their treatment plans, which are not proven to be effective in preventing the medical conditions and diseases they claim to target. Despite growing concerns over these clinics,...
How the FDA Got Her Groove Back (With CBD Warning Letters)

How the FDA Got Her Groove Back (With CBD Warning Letters)

The FDA has changed its approach when enforcing compliance for nicotine and cannabis products. Whereas previously the FDA was practicing enforcement discretion, often limited by the lack of guidance and will, the FDA is slowly solidifying its stance on how it will...
Addressing the Opioid Crisis

Addressing the Opioid Crisis

Although pharmaceutical drugs have been blamed for their role in the opioid crisis, they are not the only factors at play. In addition to bad players in the pharma industry, including the producer of Oxycontin, clinicians have also played a role in the ongoing...
How to Communicate Effectively with the FDA

How to Communicate Effectively with the FDA

Opening up lines of communication with the U.S. Food and Drug Administration (FDA) can often be intimidating for companies, and the process does not seem straightforward.  Fortunately, there are many ways of undertaking this process–whether it be because your...
Anti-Kickback Settlement Surge

Anti-Kickback Settlement Surge

Recent Increase in Anti-Kickback Settlements Among Drugmakers Already, the month of June has seen drugmakers Mallinckrodt and Insys face settlements with the Department of Justice due to allegations that they had bribed doctors and set up sham speaker programs.  These...
FDA Releases Guidance on Marketing Vaping Products

FDA Releases Guidance on Marketing Vaping Products

Although e-cigarettes were initially introduced as a less harmful alternative to traditional tobacco products, and meant to be a way for smokers to slowly decrease their consumption of nicotine, the marketing tactics used to advertise these products have recently come...

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.