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.
Navigating the Minefield of Cosmetic Claims: A Decision-Tree Approach On the health and beauty shelves, a compelling claim can be the difference between a bestseller and a product that gathers dust. However, the stakes for getting those claims wrong have never been higher. From regulatory bodies like the FDA and
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
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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
Navigating the Minefield of Cosmetic Claims: A Decision-Tree Approach On the health and beauty shelves, a compelling claim can be the difference between a bestseller
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