FDA

The US Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) recently issued an enforcement letter…

On July 31, 2019, the United States Department of Health and Human Services (HHS), in conjunction with the Food and Drug…

Recently, the US Food and Drug Administration (“FDA”) published a new draft guidance entitled Opioid Analgesic Drugs:…

The FDA’s Office of Prescription Drug Promotion (OPDP) issued its second untitled letter of the year to California drugmaker Vivus…

The US Food and Drug Administration (“FDA”) recently published a notice in the Federal Register seeking to find out more about how…

The FDA issued a final guidance on the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors…

The Trump administration recently issued new guidelines that will expand White House and congressional oversight and review of…

As reported by Regulatory Focus, a new review of studies of direct-to-consumer (DTC) prescription drug advertising identifies…

On May 8, 2019, the Department of Health and Human Services (“HHS”) announced a final rule that will require direct-to-consumer…

According to research funded by the FDA and published last month, participants in a study on direct-to-consumer (DTC) advertising…