Weekly Roundup 5.15.15

Today is one of those days where if you took the date and read it backwards – 5.15.15, it would still be the same date and it has pretty much been that way all week. 5.14.15, 5.13.15 and so on. So there’s that. And it was a busy one for me – I could barely hang on. And I didn’t get to my AdComm posting that I had intended, but promise to next week.

And it is Spring. So there.

In the meantime, a bit of what happened this week:

  • House E&C Sets Another Opioid Hearing – The House Energy and Commerce Committee, Subcommittee on Oversight and Investigations has scheduled  another hearing regarding opioid abuse. The subcommittee has already held several meetings and brought numerous people forward under various subject headings, including academia, federal officials and local communities. This Thursday, the category under examination is “What are State Governments Doing to Combat the Opioid Abuse Epidemic”. The materials for the hearing will be found here.
  • AdComm Recommends Approval on Cystic Fibrosis Compound – It is always interesting to watch media coverage around an advisory committee meeting called to consider an application for approval for a new compound. As the FDA documents are posted to the committee docket prior to the meeting, there is a tendency for headlines to express the questions raised by FDA staff as they pick through the clinical history of an investigative compound, resulting in headlines that dwell on the negative side. But then the actual deliberations occur and a different outcome emerges, which was the case this week when the Pulmonary-Allergy Drugs AdComm voted 12-1 to recommend approval for a new cystic fibrosis treatment. The reported PDUFA date is July 5, however that falls on a Sunday, so it would likely be sooner.

That’s it for me this week and my apologies for the late posting. Time is not what it used to be. Hope you all had a good weekend.

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