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.
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.
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 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.
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.
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.
The U.S. Food and Drug Administration took a significant step forward in driving the efficient development of novel diagnostic technologies that scan a person’s DNA to diagnose genetic diseases and guide medical treatments. For the first time, the agency has formally recognized a public database that contains information about genes, genetic variants and their relationship to disease.
The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.
The U.S. Food and Drug Administration approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.
The U.S. Food and Drug Administration approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation Assay, developed by Invivoscribe Technologies, Inc., is used to detect the FLT3 mutation in patients with AML.