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 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 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:
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:
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.
The Food and Drug Administration ordered a Canadian device manufacturer to stop marketing its device in the U.S. for unapproved uses, and renew its lapsed registration, in a warning letter dated March 13. According to FDA, Body, Mind & Soul, Inc. is marketing its “Celluderm,” a therapeutic massager, for uses as diverse as boosting the immune system, reduction of water retention, relief of headaches and restless legs, and breast cyst reduction. Marketing for new intended uses requires premarket notification to the agency. Without a premarket approval notification (PMA), its device is adulterated. The company did not complete a facility registration for 2013 either, FDA said.
On March 26 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 posted two frequently asked questions documents on its Jan. 16 produce safety (here) and hazard analysis and preventative controls proposed rules (here) (see 13010805 and 13010429, respectively). The Food Safety Modernization will require importers to verify compliance with the final versions of these produce safety and preventative controls rules, as part of the Foreign Supplier Verification Program (FSVP).