IoT Security Blog

Articles and Posts on IoT Security, Embedded Systems, and the Internet of Things

FDA

INTERPHEX Insights

Submitted by Joanne C. Kelleher Last week I attended part of the INTERPHEX Conference which offered technology solutions and education for every aspect of drug manufacturing from process development through delivery to market. I was there to see the panel presentation put on by members of the RFID Security Alliance and moderated by SecureRF’s CEO,…

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Safety Gap? The FDA has an Information Technology Chasm too.

Contributed by Joanne C. Kelleher I have written several entries about food and drug safety, RFID tracking and the FDA including: Food Production and Safety Safeguarding America’s Pharmaceuticals FDA Tracking Requirements: Drugs, Medical Devices, Why Not Food Too? RFID and ePedigree Won’t Help these Twists in the Pharmaceutical Supply Chain After reading The Safety Gap by…

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Food Production and Safety

Contributed by Joanne C. Kelleher The issue of food production and safety is continuing to get a lot of press. The New York Times Sunday Magazine for 10/12/2008 is the Food Issue. http://www.nytimes.com/pages/magazine/index.html I recommend you check out the lead story, Farmer in Chief, which provides recommendations on what the next president can and should do…

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FDA Tracking Requirements: Drugs, Medical Devices, Why Not Food Too?

Contributed by Joanne C. Kelleher The July 10, 2008 issue of The New York Times had an article about the nation’s salmonella outbreak called As Outbreak Affects 1,000, Experts See Flaws in Law. http://www.nytimes.com/2008/07/10/health/policy/10tomato.html?_r=1&th=&adxnnl=1&oref=slogin&emc=th&adxnnlx=1215698952-7EHBT2ulOF3rVfXSiXFHsA The article says; Dr. David Acheson, the agency/s associate commissioner for foods, said in a telephone interview on Monday that the…

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Secure RFID For Drug E-pedigree

Contributed by Joanne C. Kelleher In March, I wrote how the FDA was seeking comments on how to handle prescription drugs. See https://www.securerf.com/RFID-Security-blog/?p=48. Now that the date for providing comments has passed, RFID Journal has summarized the submissions. Industry Opinion Favors RFID for Drug E-pedigree Comments received by the FDA show a preference for RFID…

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Safeguarding America's Pharmaceuticals

Contributed by Joanne Kelleher Bill H.R.5839, Safeguarding America’s Pharmaceuticals Act of 2008 – to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs – was introduced to the US House of Representatives in late April 2008 by Congressman Steve Buyer (R-IN) and Congressman Jim Matheson (D-UT). According to a press…

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FDA Seeking Comments on How to Handle Prescription Drugs

Contributed by Joanne Kelleher FDA Amendments Act of 2007 (FDAAA), Section 505D(b)(3) states that the standards developed for identification, validation, authentication, and tracking and tracing of prescription drugs shall address promising technologies, which may include(A) radio-frequency identification; (B) nanotechnology; (C)encryption technologies; and (D) other track and trace or authentication technologies. As instructed by Congress in…

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Congress approves FDA Bill with section for Pharmaceutical Security

Posted by Joanne C. Kelleher  Late last week Congress sent to the White House H.R.3580.  The full title of this legislation is “To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with…

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