Top News in the Pharma World:
ELF BAR/EB DESIGN
The FDA has taken action against 22 retailers for illegally selling Elf Bar/EB Design e-cigarettes, which are popular among young people. It’s the first time the FDA has sought the maximum penalty of $19,192 for this type of violation. The FDA issued 168 warning letters to other retailers and is committed to enforcing the law and taking illegal e-cigarettes off the market, especially those that appeal to young people. Only FDA-authorized tobacco-flavored e-cigarettes can be legally sold in the U.S. The FDA will continue to take action against those involved in making, distributing, importing, or selling unauthorized e-cigarette products.
INVITAE COMMON HEREDITARY CANCERS PANEL
Great news! The FDA has approved an amazing genetic test called Invitae Common Hereditary Cancers Panel. It helps to detect your cancer risk by checking your DNA from a blood sample for variations in 47 cancer-related genes. This test is the first of its kind to receive FDA approval, and it gives fast and accurate results using next-generation sequencing.
Cancer is a significant concern in the US, but the Invitae Common Hereditary Cancers Panel can help identify your inherited risk for various cancers. It’s a good idea to talk to your doctor or a genetic counselor about your personal and family cancer history.
It’s important to keep in mind that this test does not cover all genes related to cancer risk. It’s typically done in a healthcare facility and analyzed in a lab. The results depend on scientific evidence and databases. However, this test can identify BRCA1, BRCA2, Lynch syndrome genes, CDH1, and STK11, which are some of the genes linked to cancer risk.
The FDA approved this test through the De Novo pathway for moderate-risk devices of a new type, demonstrating high accuracy through extensive testing. There are some risks associated with this test, such as false positives, false negatives, and potential misinterpretation of results. So, it’s important to keep in mind that genetics are not the only factor in cancer risk.
The FDA is working hard to make sure this test is safe and effective. They’re implementing special controls for labeling and performance testing, so similar devices can go through a streamlined approval process in the future.
What's New To The Market?
If you suffer from moderately to severely active ulcerative colitis, Velsipity may be the treatment for you
Zurzuvae is a medication that can help with postpartum depression
Exxua can help with major depressive disorder
It is always recommended to check with your healthcare providers and insurance provider for more information about coverage and available treatments.
DEA National Take Back Day !
Join us for National Prescription Drug #TakeBackDay on Friday, October 28th, between 10am and 2pm! Discover collection site locations near you www.DEATakeBack.com
The drug overdose epidemic in the United States poses a serious threat to public health, safety, and national security. The National Prescription Drug Take Back Day, organized by the DEA, reflects their commitment to safeguarding Americans’ health and well-being. This initiative encourages the public to eliminate unnecessary medications from their homes, as a way of preventing medication misuse and opioid addiction from ever taking hold.
The DEA is dedicated to creating safer and healthier communities, and one way to achieve this is by reducing overdoses and overdose deaths. While the community does its part by turning in unneeded medications and keeping them out of harm’s way, we are also doing our part to further reduce drug-related violence..
