USFDA

- Read more about FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards
The U.S. Food and Drug Administration has posted warning letters to five companies who produce products labeled as homeopathic for significant violations of current good manufacturing practice (CGMP) regulations. Four of the warning letters pertain to companies who jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their purportedly sterile products were not shown to be sterile. An additional letter outlines a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.
- Read more about FDA policy advancements to help bring interchangeable biosimilars to market
The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics.
- Read more about FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable on a milligram to milligram basis and their recommended doses differ.
- Read more about FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder
The U.S. Food and Drug Administration approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for use in adults.
- Read more about First FDA-approved vaccine for the prevention of dengue disease in endemic regions
The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.
- Read more about FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to get a better sense of how the organs are working when they are perfused with a solution outside the body to better determine whether the lungs can then be viable for transplant.
- Read more about Alembic Pharmaceuticals receives USFDA Approval for Teriflunomide Tablets 7 mg and 14 mg
Alembic Pharmaceuticals Limited announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg.
- Read more about FDA approves first targeted therapy for metastatic bladder cancer
The U.S. Food and Drug Administration granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy. Patients should be selected for therapy with Balversa using an FDA-approved companion diagnostic device.
- Read more about FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion
U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care.
- Read more about FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications
U.S. Food and Drug Administration issued a warning letter to Inova Genomics Laboratory (Inova) of Falls Church, Virginia, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness. The tests claim to predict patients’ responses to specific medications based on genetic variants. Selecting or changing drug treatment in response to the test results could lead to potentially serious health consequences for patients.