Weekly Roundup 4.3.15

March winds bring April showers. April showers bring May flowers.  May flowers bring pilgrims. Ha.

It is April – 2015 speeds at a breath-taking speed. The yard work continues to wait, but the daffodils do not and have arrived in time for this holiday weekend.

On a more official front, Dr. Margaret Hamburg, certainly an effective presence as FDA Commissioner these past six years, gave her final public speech last Friday at the National Press Club. Prior to her arrival, the agency hungered for steady leadership. We wish her well.

In the meantime, here are a few other things that occurred this week of note:

  • Stepping Up with Opioid Guidance – A few weeks ago, you may have read that FDA was coming under some Congressional pressure to come through with a final guidance on the development of opioid products with abuse deterrence and reportedly if not delivered, there was some funding at stake. This week the agency announced delivery of an opioid guidance. The agency said that while the technology is evolving it was issuing the guidance was meant to assist those developers wishing to apply a deterrence factor. No mention of the Congressional boost to the timing, but perhaps social media guidance advocates may want to take notes.
  • AdComm to Discuss Blood Donor Policy and Gay Men – In the wake of the HIV epidemic that began in the early 1980s, FDA put into place a lifetime ban on donations from gay men/men who have had sex with men if sex had occurred at any time since 1977. Late in 2014, FDA Commissioner Hamburg announced a proposed change in the policy to defer such donations if sexual relations had occurred within the past year. The agency is announcing that the topic will be reviewed, among other agenda items, at an upcoming Blood Products Advisory Committee to be scheduled for May 13.
  • AdComm Name Change – For those of us who watch FDA’s advisory committee meetings closely, take note that the Anti-Infective Drugs advisory committee has taken on a new name and will now be known as the Antimicrobial Drugs Advisory Committee.  Notice of the change is being noted in the Federal Register and was effective March 4 as can be seen here on the Committee’s home page.

That’s it for me this week folks. I hope you all have a wonderful weekend. Be safe and well.

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