MDL requires MDSAP certification, which the Company expects to receive shortly, at which point it will file its MDL application. Final regulatory decisions on DrugSorb-ATR are expected from FDA ...

Oct. 16, 2024 — Before the FDA allows prescription medicines on the market, drugmakers must prove they’re safe and effective. What’s less widely known is that most medical devices ...

Thermo Fisher's Greenville, N.C. plant has been found in breach of US FDA regulations, including twice this year FDA's most recent inspection of Thermo Fisher plant found shortfalls in ...

Amid an ongoing pet food recall, the U.S. Food and Drug Administration (FDA) is urging pet owners not to give their dogs and cats certain food products from two different brands. Both the brands ...

26, when the U.S. Food and Drug Administration (FDA) approved Cobenfy for the psychiatric disorder. Developed by Karuna Therapeutics, which was subsequently acquired by Bristol Myers Squibb ...

Friday’s approval from the FDA adds a second option for those eligible to receive the vaccine: It can be taken at home, through self-administration by adults or to children with the help of a ...

The FDA has previously granted Breakthrough Device ... which will be submitted with the expected near-term receipt of MDSAP certification.” Ticagrelor is a blood thinning drug frequently ...

Thousands of these chemicals are found in processed food, and many have never undergone FDA evaluation because they bypassed premarket review under a loophole that allows companies to declare ...

It is a severe, chronic mental illness that is often damaging to a person's quality of life," said Dr. Tiffany Farchione, director of psychiatry in the Office of Neuroscience in the FDA's Center ...

A nasal spray version of the annual flu vaccine can now be taken at home, the U.S. Food and Drug Administration (FDA) says. In a statement published Sept. 20, the FDA announced that it had ...

It also helps other companies define the "requirements related to labeling and performance testing," per the FDA, so similar at-home tests will have an easier time making it to the market and ...

pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near futureExpecting FDA and Health Canada decisions in 2025 PRINCETON, N.J., Oct. 01, 2024 (GLOBE ...