Citing a public health emergency, a group of congressional Democrats called on HHS Secretary Alex Azar to use existing legislative authority to lower the price of hepatitis C virus treatments.…

Taking some opioid painkillers increases the risk of deadly infections, according to an analysis of data from TennCare, Tennessee’s state Medicaid program. Source: Drug Industry Daily

Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Source:…

The FDA served U.K. drug manufacturer Bray Group a Form 483 after finding numerous violations during an inspection of the firm’s Faringdon, Oxfordshire facility, including problems with validations, sample testing,…

The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in…

A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA…

Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the…

FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes…