As many of us get ready to hit the road this week to spend the holiday with friends and family during this season when we give thanks and take stock of our many blessings, I will voice one now. Thanks to the many readers who have subscribed to Eye on FDA this past year, as well as the six years before. I’m indeed grateful for the opportunity to make observations, relay information, provide analysis and for interchanges with folks and for the opportunity to meet so many new people.
Despite the lack of postings this week – a busy one – here is a bit of what happened in this final full work week in November:
- FDA Clears “Next Generation” Gene Sequencing Devices – Four new diagnostic devices termed by FDA as “next generation” in high throughput gene sequencing were given marketing clearance by the agency this week. According to the release, the new technology will allow physicians to take a broader look at the genetic makeup of patients. Two of the cleared devices will be used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator gene.
- FDA Has Marshals Seize Dietary Supplements – The agency announced that it had directed a seizure of over $2 million worth of goods – 1500 cases of finished goods and 1200 pounds of in-process/raw material good – because the products contained DMAA. In 2012, FDA issued warning letters to companies to notify them that any products containing DMAA, which is not a legal component of supplements, had to be taken off the market.
- Compounding Bill Passes Senate – By a voice vote this week, the Senate passed legislation passed by the House of Representatives in September that would give FDA additional authorities to regulate the pharmacies engaged in compounding. The Drug Quality and Security Act will require facilities engaged in compounding to report what drugs are being compounded and to submit adverse event reports and subjects the facilities to a risk-based inspection schedule, among other things. This milestone is added to the FDA and Compounding tab on the Eye on FDA website.
- Advisory Committee is No More – FDA served notice this week in the Federal Register that the Veterinary Medicine Advisory Committee was terminated as of September 24, 2013. No explanation was provided in the notice other than to say that the committee had been formed to review the safety and efficacy data for new animal drugs, feed and devices.
Be well. Be safe. For those in the U.S. – have a wonderful Thanksgiving. See you next week.
