These guidance documents lay out the FDA’s recommendations for how to comply with applicable DSCSA requirements, including those for enhanced drug distribution security at the package level that go into effect in November 2023. Keep Reading
The FDA’s investigation identified Thomson International Inc. of Bakersfield, California, as the likely source of contaminated red onions. Keep Reading
The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products. Keep Reading
The FDA and CDC believe there is adequate supply of respirators to transition away from use of decontamination and bioburden reduction systems. Keep Reading
As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. Keep Reading
FDA believes this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing. Keep Reading
Based on the scientific information that continues to be made available over the course of the pandemic, the USDA and FDA continue to be confident in the safety of the food available to American consumers and exported to international customers. Keep Reading
Bamlanivimab and etesevimab are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. Keep Reading
The nine pounds of pills were seized for unlawful importation of mediation. The pills have an estimated manufacturer’s suggested retail price (MSRP) of approximately $96,608. Keep Reading
Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Keep Reading
This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software. Keep Reading
Agency takes further steps to strengthen the REMS program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the benefits of these drugs continue to outweigh the risks. Keep Reading
The U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Keep Reading
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Keep Reading
Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. Keep Reading
In 2017, the Food and Drug Administration created a new office within the agency to oversee its lab safety program. But, 3 years later, there are still disagreements within the FDA about the office's roles and responsibilities. Keep Reading
The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. Keep Reading
The agency has discovered that some hand sanitizers are being packaged in beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles. Additionally, the FDA has found hand sanitizers that contain food flavors, such as chocolate or raspberry. Keep Reading
This method was used in our current investigation and may be instrumental in our efforts to better understand the dispersion of the parasite in the environment, which could help prevent future outbreaks. Keep Reading
Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the overdose effects, usually within minutes. Keep Reading