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The agency may require post-marketing studies to assess serious risks related to a drug’s use, or to identify unexpected serious risks that data suggest could arise. Read More
The suit identifies a child diagnosed with opioid-related neonatal abstinence syndrome at birth in 2010 due to in utero exposure to the drugs. Read More
Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) quizzed Aetna, Anthem and United Healthcare in a Nov. 20 letter on how spending on insulin has changed over the past decade. Read More
The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on Monday that would expand the number of ways Medicare Advantage and Part D plans can negotiate lower drug prices. Read More
The measure would give the federal government the power to ignore patents or market exclusivities and approve cheaper generic versions if branded drugmakers refuse to cut prices as required. Read More
“By approving opioids indicated for the treatment of chronic pain without substantial evidence of their efficacy for this indication, the FDA has helped to facilitate the launch of the U.S. opioid epidemic,” PMRS said. Read More
Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA). Read More