Feb 6, 2024 | Drugs, FDA and USDA Regulatory Update
The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023. The guidance...
Jan 29, 2024 | FDA and USDA Regulatory Update, Foods
On January 25, 2024, the U.S. Food and Drug Administration’s Foods Program posted a list of new / updated food regulations it plans to publish in 2024 and beyond. These include: Amendments to Registration of Food Facilities February 2024. The proposed rule would make...
Jan 24, 2024 | Drugs, FDA and USDA Regulatory Update, Veterinary
The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation...
Dec 14, 2023 | Cosmetics, FDA and USDA Regulatory Update
Today, the U.S. FDA has provided an update on its ongoing activities related to serious adverse event reporting mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which are enforceable starting December 29, 2023. A responsible person is...
Dec 13, 2023 | FDA and USDA Regulatory Update, Foods
The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled Menu Labeling: Supplemental Guidance for Industry (Edition 2). To respond to frequently asked questions regarding menu labeling requirements, the draft...
Nov 8, 2023 | FDA and USDA Regulatory Update
Today, the U.S. Food and Drug Administration (FDA) announced its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)...
