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- Read more about FDA new actions advancing the agency’s biosimilars policy framework
The bedrock of our mission is our consumer protection role – our obligation to protect patient safety. Part of our mission also inspires us to promote beneficial innovations that can advance patient care.
- Read more about NIH to fund HIV care and prevention research in vulnerable southern U.S. communities
The National Institute of Allergy and Infectious Diseases will fund a series of collaborations with medical research institutions in the southern United States to test new ways of implementing HIV treatment and prevention tools in counties with some of the highest rates of new HIV cases nationwide. The U.S. South overall has the highest rates of new HIV diagnoses, people living with HIV, and HIV-related deaths of any U.S. region.
- Read more about Tanzania is first African country to reach an important milestone in the regulation of medicines: WHO
Tanzania is the first confirmed country in Africa to achieve a well-functioning, regulatory system for medical products according to the World Health Organization (WHO). This means that the Tanzania Food and Drug authority (TFDA) has made considerable improvements in recent years in ensuring medicines in the healthcare system are of good quality, safe and produce the intended health benefit.
- Read more about FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
The U.S. Food and Drug Administration released a warning letter issued to Zhejiang Huahai Pharmaceutical Co. Ltd. (ZHP), in Linhai, Taizhou Zhejiang China, the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity.
- Read more about Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder
Sandoz Inc., a division of Novartis, and Pear Therapeutics, Inc., the leader in prescription digital therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for reSET-OTM.
- Read more about Myriad Validates Polygenic Score to Predict Breast Cancer Risk in Women of Hispanic Ancestry Who Test Negative for Hereditary Cancer Mutations
Myriad Genetics, Inc a leader in molecular diagnostics and personalized medicine, today announced results from an important study to validate the polygenic component of a forthcoming riskScore™ test for Hispanic women who test negative for a hereditary cancer mutation with the myRisk® Hereditary Cancer test. The results are being presented at the 2018 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
- Read more about FDA’s new effort for developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products
One challenge FDA face right now, when it comes to developing diagnostics that can help target the delivery of cancer drugs, is the way these diagnostics are sometimes labeled.
- Read more about Elevated hormone flags liver problems in mice with methylmalonic academia: study
Researchers have discovered that a hormone, fibroblast growth factor 21 (FGF21), is extremely elevated in mice with liver disease that mimics the same condition in patients with methylmalonic academia (MMA), a serious genomic disorder. Based on this finding, medical teams treating patients with MMA will be able to measure FGF21 levels to predict how severely patients’ livers are affected and when to refer patients for liver transplants. The findings also might shed light on more common disorders such as fatty liver disease, obesity and diabetes by uncovering similarities in how MMA and these disorders affect energy metabolism and, more specifically, the function of mitochondria, the cells’ energy powerhouses. The study, conducted by researchers at the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health, was published Dec. 6 in JCI Insight.
- Read more about Low-income, rural kids at higher risk for second- or third-hand smoke exposure: study
Infants and toddlers in low-income, rural areas may be at higher risk for second- and third-hand smoke than previously reported, according to a study supported by the National Institutes of Health. Approximately 15 percent of children in the study tested positive for cotinine, a byproduct formed when the body breaks down nicotine, at levels comparable to those of adult smokers. About 63 percent of children in the study had detectable levels of cotinine, suggesting widespread exposure to smoke. The study appears in Nicotine & Tobacco Research.

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- Read more about FDA’s new strategic framework to advance use of real-world evidence to support development of drugs and biologics
The health care system is integrating more effective ways to leverage electronic tools to gather and use vast amounts of health-related data. These tools offer new opportunities to use data collected during the routine care of patients to advance medical care. Leveraging such data – typically called real-world data (RWD) - to improve regulatory decisions is a key strategic priority for the FDA. Today, the FDA is announcing our new 2019 strategic Framework for how we’ll continue to advance these opportunities.