Launching an OTC drug involves more than just mixing ingredients and designing a label. It requires strict adherence to FDA regulations and Good Manufacturing Practices (GMP). In our recent webinar, Bill Neumann, VP of QA and Regulatory Affairs, outlined a logical, 10-step process to ensure a compliant and efficient launch.
Launching an Over-the-Counter (OTC) drug in the United States is a rigorous process, but it doesn’t always require the years-long, multi-million dollar path of a New Drug Application (NDA). For most OTC products, the pathway to market relies on the OTC Drug Monograph system. But what exactly is it, and
In today’s cosmetic and personal care product market, claims such as “hypoallergenic,” “suitable for sensitive skin,” or “non-irritating” are powerful differentiators. Consumers want products that are gentle, safe, and less likely to cause adverse skin reactions. However, from a regulatory, scientific, and brand credibility perspective, such claims require solid evidence.
Launching a new product is a high-stakes endeavor. You depend on testing data to validate performance, support claims, and satisfy regulators. Yet many companies stumble before they even get to market. Below are three common “testing traps” that can silently undermine your launch readiness and what you should do to
In R&D, formulation, and for compliance teams working in cosmetics, personal care, or topical pharmaceutical products, understanding the differences between photoallergy and phototoxicity is essential to ensure product safety, meet regulatory requirements, and prevent adverse skin reactions. In this blog, we’ll review the relevant regulatory frameworks and discuss how we
Introduction: A New Era in U.S. Cosmetic Regulation The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most sweeping update to U.S. cosmetic legislation in decades. Among its many new requirements are mandates for standardized asbestos testing in talc and fragrance allergen disclosure. These mandates are not optional
When formulating sunscreen products, it’s essential to validate not only UV protection, such as SPF and broad-spectrum claims, but also thermal stability and performance under heat. Dropping Point testing is a crucial analytical method that helps in R&D, formulation, compliance, and regulatory review. What is Dropping Point Testing? Dropping Point
Understanding Burkholderia cepacia: A Hidden Threat Burkholderia cepacia complex (BCC) comprises a group of Gram-negative, rod-shaped bacteria that are notorious for their opportunistic nature. These bacteria pose a significant health risk, particularly to individuals with compromised immune systems, those who are mechanically ventilated, and patients with underlying conditions such as
Cosmetic Stability Testing: Why It Matters More Than Ever As consumers increasingly demand high-performing, long-lasting, and safe cosmetic products, stability testing has emerged as a cornerstone of modern product development. For manufacturers, formulators, and regulatory experts, it is no longer enough to launch an innovative product. Products must also remain
Pharmaceutical Stability Testing: The Key to Product Safety and Regulatory Compliance Pharmaceutical stability testing is more than a regulatory checkbox. It’s a critical scientific tool that determines whether a drug product will remain safe, effective, and consistent throughout its shelf life. For drug developers and regulatory teams, understanding the principles
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Launching an OTC drug involves more than just mixing ingredients and designing a label. It requires strict adherence to FDA regulations and Good Manufacturing Practices
Launching an Over-the-Counter (OTC) drug in the United States is a rigorous process, but it doesn’t always require the years-long, multi-million dollar path of a
In today’s cosmetic and personal care product market, claims such as “hypoallergenic,” “suitable for sensitive skin,” or “non-irritating” are powerful differentiators. Consumers want products that
Launching a new product is a high-stakes endeavor. You depend on testing data to validate performance, support claims, and satisfy regulators. Yet many companies stumble
In R&D, formulation, and for compliance teams working in cosmetics, personal care, or topical pharmaceutical products, understanding the differences between photoallergy and phototoxicity is essential
Introduction: A New Era in U.S. Cosmetic Regulation The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most sweeping update to U.S. cosmetic
When formulating sunscreen products, it’s essential to validate not only UV protection, such as SPF and broad-spectrum claims, but also thermal stability and performance under
Understanding Burkholderia cepacia: A Hidden Threat Burkholderia cepacia complex (BCC) comprises a group of Gram-negative, rod-shaped bacteria that are notorious for their opportunistic nature. These
Cosmetic Stability Testing: Why It Matters More Than Ever As consumers increasingly demand high-performing, long-lasting, and safe cosmetic products, stability testing has emerged as a
Pharmaceutical Stability Testing: The Key to Product Safety and Regulatory Compliance Pharmaceutical stability testing is more than a regulatory checkbox. It’s a critical scientific tool