More than 102 million U.S. households own a dog or a cat, and thousands more have fish, birds, or reptiles. The resulting pet ...

The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...

This article explores how the Food and Drug Administration (FDA) regulates dietary supplements, the challenges of ensuring quality control, and what consumers should know before purchasing dietary ...

Maintaining cold chain compliance is crucial for protecting product integrity, worker safety, and minimizing costs, while ...

As Wilson Sonsini previously reported,1 the U.S. Food and Drug Administration (FDA) had been preparing the industry to comply with the 2024 LDT ...

FDA guidance followed in February 2012 ... This is the focus of biosimilar regulation. HB: One of the biggest challenges for start-up biotech companies is in understanding regulatory requirements ...

By Steven Grossman Secretary Kennedy’s announcement came last Thursday: FDA’s contribution to the pending HHS reduction in force (RIF) would ...

AliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its MosaiQ AiPlex Connective Tissue Diseases (CTDplus) microarray. This ...

AI’s reach depends on the environments in which it operates as well as how it is developed and deployed, highlighting a ...

"The ongoing gutting of the FDA is likely to cause American deaths," said the CEO of one medical device developer.

Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...