This is just awful. A whole week without a posting. Not because I did not have anything to talk about, but because I did not have anything like time on my side. It was one of those weeks. I did have time during my dog walks, however, to note that my neighborhood is almost wholly infused with the sublime scent of honeysuckle, reminding me of being a child in my grandmother’s garden. I have always liked honeysuckle. It is also a harbinger in my mind that summer is just about here. As a kid, the period after Memorial Day was the beginning of summer, even though it doesn’t officially begin until later in the month, emotionally speaking – it is summer!
And for those not interested in that, but in FDA, there were a lot of things popping this week and here are a few of them:
- FDA OKs Test for Identifying Certain Types of Kidney Disease – The agency announced this week that it would allow marketing of the first non-invasive test that would help identify when a specific type of kidney disease is due to autoimmune causes or because of infection. The condition is called membranous glomerulonephritis (MGN) which is a chronic disease that can cause damage to a cluster of blood vessels in the kidney and which can damage the kidney as it progresses. The test is called the EUROIMMUN Anti-PLA2R IFA blood test. Since treatment depends on the kind of disease one is experiencing, the test can help in getting access to treatment according to the FDA spokesperson. While the test helps determine the cause, the test should not be used alone to diagnose.
- Agency Approves First Implantable Device with Remote Monitoring to Measure Pulmonary Artery Pressure – There was just no way to shorten that headline. But speaking of approvals of a first kind for a device, here is another one. FDA approved CarioMEMS HF System which is an implantable wireless device that measures the pulmonary artery (PA) pressure and heart rates of patients with Class III heart failure who have been hospitalized within the previous year. The goal of having such a system is to reduce possible future heart failure-related hospitalizations by providing data from the home that can be reviewed by physicians who can then make treatment decisions.
- Draft Guidance on Proprietary Names of Drugs – A not uncommon question about drugs is about the process for naming them. Here to shed some light on the process is a draft guidance issued by FDA entitled “Best Practices in Developing Proprietary Names for Drugs“. It focuses on the safety aspects for naming, i.e., avoiding medication errors with similar names and provides a systematic framework for evaluating names before submitting them to the agency for review. FDA held public meetings in 2003 to discuss the topic and again in 2008. Interested persons can comment on the draft guidance at www.regulations.gov.
- Final Guidance on Expedited Programs for Serious Conditions – Drugs and Biologics – After initial publication last year on a draft guidance, FDA issued a final guidance entitled “Expedited Programs for Serious Conditions – Drugs and Biologics” that is intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies, while seeking to preserve the standards for safety and effectiveness. Among other things, the Guidance provides definitions for the concept – a serious condition, available therapies, unmet medical need and delineates the differences between Fast Track, Breathrough Therapy, Accelerated Approval and Priority Review.
- Before You Get in That Tanning Bed – You should probably know that this week FDA moved to reclassify sunlamp products from Class I (low risk) to Class II (moderate risk), requiring the products to carry a visible black-box warning that explicitly states that it should not be used on persons under 18 years of age and added information and warnings to be included in marketing materials.
That’s it for me this week. Again sorry for the lack of posts this past week. Busy, busy, busy. Have a good weekend everyone!