The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...

The FDA in July 2025 made publicly available over 200 complete response letters—an initiative that the investment community ...

Stores that may have carried two affected products are mostly concentrated in the East, but also spreading nationwide.

FDA will convene the Pharmacy Compounding Advisory Committee (PCAC) on July 23-24, 2026, to discuss seven peptides for potential inclusion on the 503A bulks list. An additional five peptides will be ...

Food and Drug Administration Deputy Commissioner for Food Kyle Diamantas said his agency's agenda has support "from the very top" of the Trump administration.

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more ...

Under new Food and Drug Administration (FDA) guidance on "low risk" wearable technology and software, AI-powered health tools are rapidly expanding, leading to major implications for cost, access, and ...

Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain ...

WASHINGTON (AP) — A Democratic lawmaker raised new concerns about a Food and Drug Administration program designed to drastically shorten the review of certain drugs, including whether senior officials ...

U.S. Food and Drug Administration "enforcement in the social media space has historically been somewhat limited, but recent ...

The U.S. Food and Drug Administration (FDA) has signaled renewed regulatory focus on the long-standing practice of “self-affirmed” GRAS determinations. Although the GRAS (Generally Recognized as Safe) ...