There hasn’t been a Weekly Roundup for the past few weeks, but news has been slow and life has not, so apologies. It seems the shorter days of Winter make it more challenging for me to get all the things done that I need to get done. Once the sun sets, I’m not good for much.
We are in the throes of getting to the wild swings of weather characterizing the latter part of winter. Snow one day, rain the next, followed by fog. Those daffodils that came up early are regretting it.
In the meantime, some of what has transpired:
- FDA Issues Guidelines on Blood Supply and Zika – As a measure to protect the blood supply from Zika FDA issued guidance this week related to blood collection acting after reports of possible transmission outside the U.S. through transfusion. The agency has taken a two-level approach – one for those in areas where there is not active transmission where the agency is recommending that individuals who are at risk of having been exposed to Zika be deferred from donating blood for a 4 week period. At risk is defined as having had symptoms of infection with the virus, those who have had sexual relations with someone who has traveled to an area where there is active Zika transmission during the past three months, and those who have traveled to locales where there is active transmission within the past four weeks. No mention is made of sexual contact with a person who has been showing symptoms. For areas where there is active transmission, whole blood should only be obtained from areas where there is no active infection. Further information is available in the FDA release on the matter. Undoubtedly, policy will be evolving and expanding.
- Complete Response Letter Issued for Cardio Combo – In December 2015, an FDA Advisory Committee voted against recommending approval for an expanded indication for the combination of ezetimibe and simivastatin. While currently approved for the treatment of people with elevated LDL cholesterol for those with hyperlipidemia, the expanded indication would have included use for coronary heart disease patients to reduce cardiovascular risk. This week FDA followed the recommendation of the committee and issued a complete response letter.
- FDA to Offer Docs Course on Biosimilars – The FDA blog – FDAVoice – published a posting this week announcing that the agency would be offering health care providers a free course designed to help in their understanding of biosimilars. The course – FDA Overview of Biosimilar Products – is set to provide information about the development process and approval pathway that FDA is using to regulate the approval of biosimilar products and with the stated goal of helping develop an understanding of the relationships between biosimilars and products that are interchangeable.
That’s it for me this week folks. Have a wonderful weekend.
