Senate Committee Favors Bill Allowing FDA to Regulate Compounders
A debate is still ongoing as to whether or not the Food and Drug Administration should be granted extended regulatory powers over compounding pharmacies. The issue was brought to the forefront after contaminated steroid injections from the New England Compounding Pharmacy led to a widespread outbreak that claimed the lives of more than 50 people… read more
FDA Works to Protect Citizens From Antibiotic-Resistant Microorganisms
The Food and Drug Administration has grown increasingly concerned about the prevalence of bacteria that is resistant to antibiotics. Although antibiotics are certainly a valid treatment option when dealing with infectious organisms, over the course of time, certain organisms have developed a resistance to the very drugs meant to fight them. In a new report,… read more
FDA Seeks To Get Minorities More Involved in Clinical Trials
In a new report, the Food and Drug Administration explains how the agency is attempting to bolster the efficacy of clinical trials by pushing for more minorities to be involved with said trials. Getting people of varying backgrounds and ethnicities into these trials is vital for drug makers looking to exhibit the safety and effectiveness… read more
FDA Details Efforts To Eradicate Polio Worldwide
A Food and Drug Administration news release explains the agency’s efforts to reduce the threat of polio around the world. Although vaccines have pretty much eliminated the disease from America, that isn’t the case in the rest of the world, where certain countries are still privy to the disease. Kids under five are particularly at… read more
FDA Program Seeks to Root Out Counterfeit Malaria Medication
As society becomes more and more globalized, the Food and Drug Administration is turning its eye toward improving the safety of drugs and food products all around the world. In a new report, the agency describes how they’re taking a device readily available in the United States and using it to keep citizens in Southeast… read more
Website Marks The Latest Facet of the FDA Patient Network
The Food and Drug Administration, in its ongoing quest to protect citizens and educate patients on safety matters, has just launched a website for the FDA Patient Network. Those interested in learning more about medical devices and medications are encouraged to visit. The FDA Patient Network was ostensibly started in 2011 when Patient Network News… read more
FDA Faces New Round of Questioning Over Compounder Regulation
In the past few weeks, compounders have been recalling sterile products in droves over concerns that said sterility cannot be assured. Many of those recalls have stemmed from inspections by the Food and Drug Administration that uncovered the types of conditions that could lead to contamination. Nevertheless, the Commissioner of the FDA feels that current… read more
FDA Details The Efforts of the Office of Minority Health
The Food and Drug Administration has issued a report detailing the work being done by the agency’s Office of Minority Health. The report comes as part of Minority Health Month, which will find the organization releasing similar informational materials up until the end of April. The OMH came about in 2010 thanks to the Affordable Care… read more
Changes on the Way For Nicotine Replacement Therapy Labels
The Food and Drug Administration is making changes to the way they oversee nicotine replacement therapies, removing some warnings because they believe that heretofore perceived threats have now been disproven with the arrival of data from a host of clinical trials and other research. Specifically, the FDA is no longer concerned that over the counter… read more
FDA Explains Migraines And Potential Treatment Options
Those who have had to deal with migraines can attest to the negative impact that the malady can have on one’s way of life. A new briefing from the Food and Drug Administration explores the prevalence of migraines in society and highlights the ways that people can combat the pain. As with anything, it’s important… read more
Calcitonin Salmon Osteoporosis Treatment Discouraged by FDA Panel
A Food and Drug Administration advisory panel has come to the conclusion that the risks of calcitonin salmon when used as an osteoporosis treatment in women who have gone through menopause outweigh the benefits, and thus the substance should no longer be marketed for that treatment. The calcitonin salmon is meant to limit the risk… read more
Da Vinci Surgical System Adverse Event Reports Prompt FDA Inquiry
The Food and Drug Administration is currently looking into whether or not a device meant to aid in a surgeon’s ability to safely conduct procedures instead poses a risk to patients. In doing, the agency hopes to establish whether or not user error or a problem with the device itself could be to blame for… read more