Weekly Roundup 3.20.15

There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that Spring starts today.  As to that though, you wouldn’t know it to look around Washington, D.C. or anywhere around the East Coast I should think – where we see snow falling outside the window today, though Spring does not officially start until 6:45 this evening here. And tomorrow promises sunshine and moderate temps.

Here is a bit of what happened this week:

  • FDA Approves New Drug for Bile Acid Synthesis Disorders – Another in what has been a long string of FDA approvals for new products that treat rare disorders, the agency announced this week approval of Cholbam for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects. People with this disorder experience a reduced bile flow and accumulation of potentially toxic bile acid intermediates in the liver and malabsorption of fats resulting in possible liver injury.
  • Opioid Abuse Hearing – The House Energy and Commerce, Subcommittee on Oversights and Investigations announced that it has set March 26 for a hearing “Examining the Growing Problems of Prescription Drug and Heroin Abuse:  State and Local Perspectives“. The slate of speakers has not yet been posted but will be found here. Also this week in related news, it was reported that members were applying pressure to FDA to issue its guidance on abuse-deterrent opioids.
  • Ebola Vaccine AdComm – A meeting of the Vaccines and Related Biological Products Advisory Committee was announced this week for May 12 to consider the development and licensing of vaccines for Ebola. When posted, meeting materials will be found here. On a related note, there was also a posting on FDA’s Voice Blog called Turning the Tide on Ebola describing on the ground work in Liberia.

I have some good stuff coming up if I can just get time to tend to it. In the meantime, enjoy this first weekend of Spring!

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