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...
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...
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...
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...
8 Ways to Bring a Product to Market Without FDA Approval

8 Ways to Bring a Product to Market Without FDA Approval

Bypassing FDA Approval and Bringing Your Product to Market Faster Although it may seem that products must go through the process of obtaining the U.S. Food and Drug Administration’s (FDA)  approval to be considered safe for consumers, there are certain cases in which...

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.