Feb 12, 2024 | Drugs, FDA and USDA Regulatory Update
The FDA has issued a final Guidance Document to assist drug establishment registrants with understanding the CARES Act reporting requirements. Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act guidance offers very...
Feb 6, 2024 | Cosmetics, Dietary Supplements, Drugs, FDA and USDA Regulatory Update, Foods, Medical Devices, Tobacco, Veterinary
FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct...
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The FDA has issued a draft guidance document discussing Quality Considerations for Topical Ophthalmic Drug Products intended for topical use in and around the eye. This is an update to the draft guidance of the same name released in October 2023.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 | Drug and Device Corner, Drugs, Medical Devices, Uncategorized
Reminder that per the CARES Act of 2020, drug establishments are required to report NDC volumes annually. This applies to all facilities that manufacture, prepare, propagate, compound, or process drugs for commercial distribution in the United States. Although the FDA...
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The FDA has announced the availability of a draft guidance for industry #286 (VICH GL60): “Good Manufacturing Practice for Active Pharmaceutical Ingredients used in Veterinary Medicinal Products.” This draft guidance has been developed by the International Cooperation...
Nov 29, 2023 | Drug and Device Corner, Drugs, Medical Devices
Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be...
