On April 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 29-31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration amended its regulations on biologics license applications, and BLA amendments and supplements, to show a change of address for the Center for Devices and Radiological Health effective April 2. The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.
The Food and Drug Administration posted a new guidance on user fees and refunds for Premarket Approval Applications (PMAs) and device Biologics License Applications (BLAs). The guidance identifies the types of PMAs and BLAs subject to device user fees, including supplements and other submissions, as well as those that don’t have a user fee, FDA said. It also identifies circumstances where the fee may be refunded. The guidance is (here).
The Food and Drug Administration is extending until July 3 the period for submitting comments on the results of its product tracing pilot. The Institute of Food Technologists submitted its report in early March on the pilot, which included companies involved in supply chains for frozen and dry Kung Pao chicken and fresh tomatoes (see 13030418). According to the report, the pilot participants appeared to have in place many of the tools necessary to capture and submit data required for product tracing, although inconsistencies in the data often delayed interpretation by IFT.
The Food and Drug Administration is revising statements required in labeling for over-the-counter nicotine replacement therapy products, it said in a notice set for publication in the April 2 Federal Register. The agency said recent evidence shows that statements on concurrent use of nicotine replacement products with other products that contain nicotine, including cigarettes, as well as a statement on use of nicotine replacement therapy products beyond the intended period, are no longer necessary to ensure safe and effective use. FDA said it is encouraging submission of supplemental new drug applications to modify these statements. See FDA’s notice for new recommended language.
On March 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 27 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
During the week of March 18-24, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of: