The Food and Drug Administration announced its fiscal year 2013 abbreviated new drug application (ANDA), prior approval supplement (PAS), drug master file (DMF), and backlog fees, pursuant to the Generic Drug User Fee Amendments (GDUFA) of 2012. The fees are effective Oct. 1, 2012, and will run until Sept. 30, 2013. Going forward, FDA will publish GDUFA fees 60 days prior to the beginning of each fiscal year, it said. GDUFA fees are expected to generate $299 million annually for FDA. The fees will be used to conduct activities such as increased inspections of foreign facilities.
On Oct. 22 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 Oct. 15-21, 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 formally announced the availability of its final guidance on the “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” in a notice set for publication in the Oct. 24 Federal Register. The guidance was issued Oct. 19, in conjunction with the beginning of food facility registration renewal. The guidance includes FDA’s determination that information about food product categories in food facility registrations is necessary for a quick, accurate, and focused response to a food safety related issue or incident, an actual or potential bioterrorist incident, or other food-related emergency, and identifies the additional food product categories included as mandatory fields in food facility registrations, as follows:
On Oct. 19-21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Oct. 17 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 sent out warning letters to six foreign device manufacturing facilities, according to recent postings on the FDA website. Xiantao Rayxin Medical Products Co. Ltd. of China (here), DMC Medical Technology & Manufacturing Co., Ltd. of China (here), and EPS Biotechnology Corp. of Taiwan (here) were each sent warning letters for deviations from current good manufacturing practice (CGMP) requirements of FDA’s quality system regulations. Accordingly, FDA said the offending products were adulterated. Warning letters sent to Nissei Precision Instruments (Suzhou) Co., Ltd. of China (here), Copious International, Inc. of Taiwan (here), and SMT-Schilling Metalltechnik GmbH of Germany (here) not only detailed CGMP violations by each firm, but also said the firms failed to meet medical device reporting requirements because they failed or refused to provide required information to FDA. As a result, certain products manufactured by Nissei, Copious, and SMT-Schilling were found to be both adulterated and misbranded by FDA.
The Food and Drug Administration issued its weekly Enforcement Report for Oct. 17 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On Oct. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: