Pharma News

Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. Overseeing the quality and safety of pharmaceutical manufacturing is key to these efforts. With the emergence of new markets, supply chains are more complex. Drug production and testing operations have also become more computerized. These changes represent new opportunities and challenges.

Researchers at Stanford University, Palo Alto, California, have created a noninvasive technology that detects when nerve cells fire based on changes in shape. The method could be used to observe nerve activity in light-accessible parts of the body, such as the eye, which would allow physicians to quantitatively monitor visual function at the cellular level. The study was published in the journal Light: Science and Applications. The work was funded by the National Eye Institute, part of the National Institutes of Health.

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WHO is proud to partner with Luxembourg, a strong supporter of global health, that contributes more than 15% of its official development assistance to the health sector. Since 2009, Luxembourg has provided 1% of its gross national income to development assistance, one of the few countries that exceeds the United Nations target of 0.7%.  

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.

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.

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.

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.

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.

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.

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.