Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products. The companies are looking to shed some light on a legal gray area that has ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

(CN) - Rejecting claims against Medtronic over its off-label promotion of a medical device, the 10th Circuit found that the company complied with federal regulations. Patricia Caplinger, of Oklahoma, ...

COLUMBUS, Ohio — After failing to pass legislation last year, sponsors of House Bill 12 introduced a different version of the bill Tuesday in hopes of its passage. The bill’s focus is on the ...

The FDA has issued a proposed rule that clarifies when drugmakers are required to update their drug labels to reflect off-label use, STAT reported. Off-label drug use occurs when a drug is used to ...

Researchers are asking for tougher penalties and fines for pharmaceutical companies that market drugs for "off label" promotion, according to a new study. Researchers describe ways that the ...

This story previously appeared in The Hill Extra. Doctors commonly prescribe drugs to treat conditions the medications weren’t designed for, but for drugmakers, discussing such “off-label” uses can ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. INDIANAPOLIS — Indiana Attorney General Todd ...

In a win for the pharmaceutical industry, the Food and Drug Administration has indefinitely delayed implementing a final rule that would give the agency greater leeway to police off-label marketing.

When you shop through retailer links on our site, we may earn affiliate commissions. 100% of the fees we collect are used to support our nonprofit mission. Learn more. Nervous about giving a big ...