The Agency improves the process for access to investigational drugs and biologics for patients who lack other options.
On June 2, the US Food and Drug Administration (FDA or the Agency) announced that it finalized three...more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.
In recent years, issues involving the integrity of and controls around manufacturing data...more
FDA agrees to allow truthful and non-misleading off-label promotion.
On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority.
On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more