In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.

The Food and Drug Administration announced it will hold the Fall 2012 Regulatory Education for Industry Conference for small businesses Sept. 19-20 in Washington, DC. At the conference, held by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), attendees will be able to network, engage with FDA experts, and learn more about FDA’s regulatory requirements for drugs and medical devices. Advance registration is required, but is free and includes training materials only, FDA said. Registration and more information on the conference available here.

The Food and Drug Administration announced the availability of a draft guidance entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” as provided by Section 102 of the Food Safety Modernization Act (FSMA). FSMA amended Section 415 of the Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.

On Aug. 13 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 Aug. 6-12, 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 of:

The Food and Drug Administration (FDA) issued the August Interstate Certified Shellfish Shippers List (ICSSL). The ICSSL is published monthly for the information and use by food control officers, the seafood industry and other interested persons. The shippers listed have been certified by regulatory authorities in the U.S., Canada, Chile, Korea, Mexico and New Zealand under the uniform sanitation requirements of the National Shellfish Program.

On Aug. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Aug. 9 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 is asking for comments on a draft guidance entitled “Refuse to Accept Policy for 510(k)s,” which explains the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. FDA’s draft guidance is not in effect, but once it’s final it will be applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Comments should be submitted by Sept. 27 to ensure consideration before the final version of this guidance is published.

On Aug. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: