In June 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Huons Co., Ltd. following an inspection of its sterile injectable manufacturing facility in Jecheon, South Korea. While Warning Letters are not uncommon in the pharmaceutical industry, this case stands out because it goes far beyond isolated documentation issues. The FDA concluded that the company's manufacturing systems, laboratory controls, and quality oversight failed to comply with Current Good...

You can no longer approach the FDA without an eSTAR. To launch a medical device in the U.S., entering the FDA’s gateway is an absolute necessity. For most companies, the preferred route is the 510(k), or Premarket Notification process. While primarily designed for Class II (moderate-risk) devices, it also applies to certain low-risk or high-risk devices depending on their unique technical characteristics. In fact, the vast majority of medical devices entering the U.S. market clear this exact...

The First New FDA Sunscreen Ingredient Addition in More Than 20 Years The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new FDA sunscreen ingredient addition to the OTC sunscreen monograph since the late 1990s. The decision represents an important regulatory milestone for the U.S. sunscreen industry and may create new opportunities for product innovation in the years ahead. What Is Bemotrizinol?...