Happy Flag Day!
It is difficult to comprehend the speed with which the year is going by – in just two weeks, 2013 will be half over. I am kind of still in 1996 in my head… In any case, this week happened, with storms to spare, and here is a bit of what happened in our corner of the world:
- There’s Got to Be a Morning After – This week FDA received approval for its plan respecting Plan B One-Step contraception to move to OTC status by the judge who ordered that restrictions to access be lifted bringing this years-long saga a step closer to some resolution. This came after the government decided to drop its efforts to appeal the federal judge’s order to make the emergency contraception available. The plan apparently applies only to the one dose version and not the two dose version which presumably it will become available once there is labeling and packaging for the product.
- Guidance Issued on Codevelopment of Two or More Investigational Drugs for Use in Combination – As combination treatments become more common, criteria for determining with codevelopment is an appropriate option and makes recommendations about nonclinical and clinical development strategies as well as regulatory process issues, including labeling issues.
- Draft Guidance on Cybersecurity of Medical Devices – Could someone hack into your pacemaker? Apparently. As described in a really interesting story in today’s Washington Post, researchers found it possible to gain access into multiple medical devices. Consequently, FDA has issued a draft guidance for comment “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” to outline issues that manufacturers might consider in preparing premarket submissions. The agency is looking for public comment on the draft guidance over the next 90 days.
- FDA Approves New Indication for Xgeva – Issuing its first press release in over two weeks, FDA announced expanded approval of Xgeva, first approved in 2010 to prevent fractures when cancer has spread to the bones, to treat adults and some adolescents with gian cell tumor of the bone (GCTB) – a rare and usually non-cancerous tumor that generally occurs in adults between ages 20 and 40.
That’s it for me this week. Please note that I have updated the legislative tab on the blog to include the latest proposed bills that would impact FDA and stakeholders, including newly proposed legislation regarding compounding. Have a good weekend everyone.
