Industry News

Spurring innovation of medical products so that patients can have access to safe, effective treatments that improve or save lives is a fundamental part of our mission. FDA is taking steps on two additional device programs: finalizing guidance on our existing Breakthrough Device Program and announcing plans for a new Safer Technologies Program (STeP).

Protecting patient safety is at the core of the FDA’s mission. All FDA-approved drugs have benefits and risks which must be weighed and balanced by health care providers and patients when making decisions about medical therapy. Our goal is to ensure that the benefits and risks are clearly articulated in drug labeling. That patients and providers have accurate information. And that the benefits outweigh the risks for the intended patient population.

The Global Health Innovative Technology (GHIT) Fund announced a total of 520 million yen (US$ 4.6 million) to support four partnerships to develop new lifesaving drugs and vaccines for malaria, tuberculosis, dengue and leishmaniasis. This includes three new projects and one that will receive continued funding.

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.

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.

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.

Meeting the goals of the Paris Agreement could save about a million lives a year worldwide by 2050 through reductions in air pollution alone. The latest estimates from leading experts also indicate that the value of health gains from climate action would be approximately double the cost of mitigation policies at global level, and the benefit-to-cost ratio is even higher in countries such as China and India.