On July 1 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 on July 2 announced its intent to step up enforcement on unapproved ear drops labeled for treatment of ear infections and inflammation (here). The agency says unapproved and misbranded single-ingredient otic drug products containing benzocaine; fixed-dose combination otic drug products containing benzocaine and antipyrine; fixed-dose combination otic drug products containing benzocaine, antipyrine, and zinc acetate; fixed-dose combination otic drug products containing benzocaine, chloroxylenol, and hydrocortisone; fixed-dose combination otic drug products containing chloroxylenol and fixed-dose combination otic drug products containing chloroxylenol, pramoxine, and hydrocortisone are being marketed without evidence of safety or effectiveness, and have resulted in several cases of allergic reactions. FDA “intends to take enforcement action against such products and those who manufacture them or cause them to be manufactured or shipped in interstate commerce,” it said.
On June 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 29 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 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 issued a guidance document on its unique device identifier (UDI) system for medical devices (here). The guidance contains information on effective dates, label contents, and which products are subject to the new requirements. The UDI system will begin taking effect Sept. 24 for Class III devices.
The Food and Drug Administration issued its weekly Enforcement Report for June 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On June 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 24 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 June 16-22, 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: