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FDA Seeks Comments on Making Enforcement Data More Accessible
October 5, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration is seeking comments on a report outlining eight draft proposals to make FDA’s compliance and enforcement data more accessible and user-friendly. They are part of FDA’s ongoing efforts to increase its transparency and part of its response to the President’s January 2011 Memorandum to federal agencies on making compliance information more publicly available and searchable online.1 Comments are due by December 2, 2011.

Revised FDA Import Alerts on Oct 3
October 4, 2011 by Elizabeth Parker|FDA and EPA

On October 3, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

EPA Finds Widely Used Chlorinated Solvent TCE to Be Carcinogenic
October 3, 2011 by Barbara Chaves|FDA and EPA

The Environmental Protection Agency has released the final health assessment for trichloroethylene (TCE) to the Integrated Risk Information System (IRIS) database. The final assessment characterizes TCE, which is a widely used chlorinated solvent, as carcinogenic to humans and as a human noncancer health hazard. According to EPA, this assessment will allow for a better understanding of the risks from exposure to TCE in soil, water and air and provide policy makers with the latest information to make decisions about cleanup and other actions to protect human health.

Revised FDA Import Alerts on Sept 30
October 3, 2011 by Elizabeth Parker|FDA and EPA

On September 30, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on Sept 29
September 30, 2011 by Barbara Chaves|FDA and EPA

On September 29, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Q&A on Arsenic in Imported Apple Juice Concentrate, Etc.
September 30, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration has updated its Questions and Answers document on the prevalence of arsenic in apple juice concentrate, including concentrate sourced throughout the world. The document was updated due to a Dr. Oz Show, and states that based on data collected by the FDA over many years, there is no evidence that juice on the market in the U.S. presents a public health risk from arsenic. The agency adds that testing results indicating total arsenic are not helpful, as it is only the inorganic arsenic (from some pesticides for example) that is harmful.

FDA Participates in Int'l Internet Week to Combat Counterfeit Medicines
September 30, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration has announced that it and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.This year’s IIWA, called Operation Pangea IV, focused on websites supplying illegal and dangerous medicines (such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin), and ran from September 20-27, 2011.

FDA Announces FURLS Registration/Listing Outage for Sept 28 - Oct 1
September 30, 2011 by Marie Rapport|FDA and EPA

The Food and Drug Administration announces that the Device Registration and Listing Module (DRLM) of the electronic registration and listing system (FURLS) will be unavailable from 12:00 PM ET on Wednesday, September 28, 2011 until 8:00 AM ET on Saturday, October 1, 2011. The 2012 Annual Registration Cycle will begin on October 1, 2011.

Revised FDA Import Alerts on Sept 28
September 29, 2011 by Barbara Chaves|FDA and EPA

On September 28, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on Sept 27
September 28, 2011 by Barbara Chaves|FDA and EPA

On September 27, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: