The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce.
The U.S. District Court for the Western District of Arkansas ordered J and L Grocery, LLC. of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne, to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.
Products imported into the United States that require screening by the Food and Drug Administration continue to increase at a rate between 5 and 10 percent annually, the FDA reports.
Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO
Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that the Food and Drug Administration ("FDA") has provided guidance to the Company following its Sprint Discussion on June 26, 2019, together with the Company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer™ (the "Reducer"), to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need.
The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.
A group of major pharmaceutical companies is asking the US Food and Drug Administration to consider changes to the agency's guidelines on developing bispecific antibodies.
A two-day Food and Drug Administration advisory committee meeting found conflicting reports related to increased late mortality rates in using paclitaxel-coated balloons (DCBs) and paclitaxel-eluting stents (DESs), according to the Regulatory Affairs Professionals Society (RAPS).
A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.
The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.
The Food and Drug Administration has been gathering comments on how to regulate cannabis products, but a cannabis industry expert says FDA should lay off and let states do their jobs.
As of this month, 27 European nations are part of a mutual recognition agreement that allows regulatory agencies such as the U.S. Food and Drug Administration to rely on drug inspection data conducted within member nations.
Test results from the Food and Drug Administration on food with high levels of fluorinated chemicals known as PFAS were dismissed by two high level officials of the FDA.
The guidance for manufacturers to submit new tobacco product applications through the premarket tobacco product application (PMTA) pathway was finalized on June 11. This is for electronic nicotine delivery systems (ENDS), like vapes, and the associated liquid nicotine.
The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs.
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On June 13, 2019, the U.S. Food and Drug Administration (FDA) issued a safety alert regarding the use of fecal microbiota for transplantation, or FMT
