Another busy week – hence a day late with the Weekly Roundup.
This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems. They took them away today. It is a good feeling. There are about 100 bags left to fill. That is a bad feeling.
It is the time of year where there are crazy temperature ranges. It was 75 degrees this week here in Washington and there is a call for snow mixed with rain. There was a thunderstorm forecast. But the daffodils are up and about to strut their stuff.
It was a relatively quiet week comparatively speaking on the FDA front, but here are a few tidbits.
- FDA Approves Inhalation Anthrax Treatment – This week the agency announced its approval of Anthasil in inhalation form to treat inhaled anthrax exposure in combination with other appropriate antibacterial drugs after rare exposure to infected animals or other exposure to spores. This product had been purchased under the authority the Biomedical Advanced Research and Development Authority (BARDA) - and the approval by FDA means that emergency authorization for its use would no longer be required. The nature of the condition being studied meant that this approval was based on animal studies and the product is made from the plasma of persons who have been vaccinated against anthrax exposure because their plasma has antibodies that act to neutralize the toxins generated by exposure.
- Blood Pump Approval – The agency announced approval of a new blood pump system for use with patients suffering effects of coronary artery disease (CAD) who are undergoing high risk procedures such as stent placement or angioplasty, known as high risk percutaneous coronary intervention. The pump is introduced prior to a procedure through a catheter. Heart function is measured and externally monitored and the pump is employed as necessary to help maintain stable heart function during the procedure. The company press release can be found here.
- Draft Guidance Development and FDA – For those who have waited for the development and issuance of a specific guidance by the agency – and waited, and waited, and waited, you may think it is just you being impatient, or just your guidance that is taking a long time to develop. In that case, you may want to take a peek at the nice overview Ed Silverman did at Pharmalot that describes just how long some guidance documents have taken to develop. As often said here, these guidance documents, along with warning letters, are the only windows into the agency’s current thinking. With the documents taking a long, long time and warning letters having slowed to a trifle the result is less transparency, not more.
That’s it for me this week folks. Have a good weekend.