One of those former FDA officials — Dr. Phil Krause — is also now criticizing moves by Makary and his aides as threatening to erode the agency's credibility.

The Food and Drug Administration’s 2022 inspection of the Sun Pharma factory in India warned of contaminations and deficiencies. But the plant received permission from the FDA to continue ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These are the key takeaways.

A federal judge on Wednesday ruled that the Food and Drug Administration’s (FDA) decision to remove popular GLP-1s from its drug shortage list, ending the sale of compounded versions of the ...

The FDA didn’t routinely test the medications for quality problems or use its vast repository of drug-related complaints to proactively track whether they were harming the people who relied on them.