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Mylan has not reached a settlement with the Justice Department to resolve allegations that it misclassified its allergy therapy the EpiPen for a Medicaid program, and as a result, underpaid state rebates, the Centers of Medicare and Medicaid said. Read More
An industry-funded study suggests that brand drug manufacturers are not taking in as much of the gross drug expenditures than they did in previous years. Read More
The FDA has introduced a new designation for regenerative medicine therapies, laying out the submission requirements for sponsors seeking the expedited review that stems from the 21st Century Cures Act. Read More
Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read More
The FDA compiled 22 case studies of different drugs, vaccines and devices that demonstrated promising results in Phase II studies, but later failed in larger Phase III clinical trials. Read More