USFDA

- Read more about FDA approves new treatment for adult patients with rare, life-threatening blood disease
The U.S. Food and Drug Administration approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease.
- Read more about FDA new steps to promote innovations in medical devices that help advance patient safety
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).
- Read more about FDA efforts to modernize generic drug labels while maintaining the efficiency of generic development
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.
- Read more about FDA efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice
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.
- 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 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 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 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.
- Read more about FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care
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.
- Read more about FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
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.