Numerous recalls have been initiated in 2025 due to the potential for damaged products, foodborne illness, contamination and ...

When it comes to off-label discussions with payers, the FDA’s final guidance now permits candid exchanges that will help facilitate coverage and reimbursement for unapproved products and ...

The Food and Drug Administration (FDA) was sued Monday by Stephen Miller's conservative group America First Legal for supposedly illegally concealing records pertaining to the off-label use of ...

MannKind Corp. (NASDAQ: MNKD) has a FDA label decision date scheduled for this Friday that has the potential to drastically alter the company's sales of its commercial drug Afrezza over time. With ...

Abortion rights groups say the FDA change will now affect laws in Ohio, North Dakota and Texas that prohibited "off-label" uses of the drug. Similar laws are on hold in Arizona, Arkansas and Oklahoma.

The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature ...

Id. The FDA cites to its guidance documents describing circumstances where it does not intend to view medical communications as evidence of off-label promotion.

Without the proper testing required by FDA approval, drugs used off-label can also be dangerous and “expose patients to risky and ineffective treatments,” according to a 2009 study.

Along with Tuesday's FDA warning, the agency also released a 164-page document with case details on 28 deaths where kratom was present, first referred to in the November 2017 advisory.

Looking more closely at the criteria defining a "healthy" food by the agency's standards, the fruits and vegetables category includes fresh, frozen, and canned produce, as well as dried fruits and ...

The FDA is updating Ozempic's warning label to acknowledge reports of bowel obstruction Mario Tama/Getty Images The FDA has issued another update to the warning label for Ozempic, saying it has ...

The FDA has proposed a rule requiring a new nutrition label on the front of most packaged foods, offering consumers easily visible information about the presence of key nutrients, according to a ...