Do I Need to Register My Dietary Ingredient with the FDA?

Do I Need to Register My Dietary Ingredient with the FDA?

How Do You Register Your New Dietary Ingredient? If a company is planning to add a new dietary ingredient to their supplement, they must ensure that all FDA regulations are being properly followed. This means notifying the FDA of the new ingredient and going through...
Do Anti-Aging Creams Work?

Do Anti-Aging Creams Work?

There are many far-reaching claims being made by cosmetics companies including suggestions that their products are anti-aging, age-defying or revitalizing. The companies are able to do so because the cosmetics industry is largely unregulated by the FDA, allowing...
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 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,...
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 other important considerations, such as which...
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...
Responding to an FDA Inspection: Preparing a War Room

Responding to an FDA Inspection: Preparing a War Room

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...
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...

Blog Disclaimer

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.