CDERs Office of Prescription Drug Promotions says its review of some voluntary submissions has slowed because the materials raise complex issues.
Former Insys Therapeutics CEO Michael Babich pleads guilty in Massachusetts federal court for his role in a nationwide scheme to bribe physicians to u...
FDA warns Akorn about CGMP violations in the production of finished pharmaceuticals at its Decatur, IL, facility.
Public Citizen says it backs legislation introduced by Sen. Bernie Sanders to require HHS to license generic and biosimilar competition in certain ins...
FDA asks members of two advisory committees to reevaluate the benefit/risk profile of Takedas Uloric in light of results of the CARES post-marketing s...
Hyman, Phelps & McNamara releases its 2018 litigation report of cases affecting FDA-regulated industries.
The Consumer Healthcare Products Associations praises House members for voting overwhelmingly to support legislation to modernize the OTC monograph sy...
FDA commissioner Scott Gottlieb unveils a new five-year strategy for the agencys Sentinel System.