Research vs Medicine

Research vs Medicine

Although the differences between research and medicine may seem clear, there are many instances in which the two terms are conflated or misused. When considering certain examples, it seems unclear whether research or medicine would be the most appropriate designation....
Cannabis Law Basics

Cannabis Law Basics

Understanding some of the basic laws and regulations guiding cannabis is critical for companies looking to remain compliant, and successfully bring their products to market. This requires not only knowing which local and federal agencies are involved in regulating...

Cannabis Law Basics (Video)

As more states move to decriminalize cannabis, the regulatory framework becomes more complicated.How can companies successfully navigate federal and state...
What is the OTC Monograph Process?

What is the OTC Monograph Process?

What is the OTC Monograph Process, and why is it important? Bringing over-the-counter (OTC) drugs to market involves three different pathways, and companies must decide which pathway is most appropriate for them. There are also other important considerations such as...

Research vs Medicine (Video)

Clinical research and medical treatment are often confused for one another, leading drug companies and healthcare professionals to risk falling out of...
Drug Snapshot: Patient Centricity

Drug Snapshot: Patient Centricity

How Can You Increase Transparency with Patients? In the healthcare industry, patient data is not often made readily available to the public. However, in response to growing pressure from patients, physicians and healthcare advocates, research data is becoming...
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...
Responding to an FDA Inspection: What Can the FDA Do

Responding to an FDA Inspection: What Can the FDA Do

In order to adequately prepare for a U.S. Food and Drug Administration (FDA) inspection, companies often need to be aware of some of the common areas targeted by the FDA, and have a thorough understanding of why these issues are addressed in FDA inspections.  This...

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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.