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If Congress were to require a Medicaid-style rebate structure for Medicare Part B prescription drugs, drugmakers would have to pay at least $1.8 billion in annual rebates — about 9 percent of Medicare’s total spending on pharmaceuticals in 2015 — according to an HHS analysis. Read More
The FDA finalized its 2015 guidance on reporting deviations for human cells, tissues and cellular and tissue-based products, also known as HCT/Ps, offering recommendations for complying with federal reporting requirements and listing the most frequent reports received by CBER. Read More
Insys Therapeutics should be prosecuted for efforts to increase use of its fentanyl spray Subsys, according to Sen. Claire McCaskill (D-Mo.), in a report from her investigation into opioid manufacturers and distributors. Read More
The European Medicines Agency revised its 2009 advice to sponsors seeking evaluations of products intended exclusively for markets outside the EU. Read More
The European Medicines Agency is implementing a new form to submit required postmarket data on safety, efficacy and quality, and it is now a mandatory part of Module 1.0 of the electronic common technical document format. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More
BIO and PhRMA filed a lawsuit challenging Nevada’s new price transparency law for diabetes drugs, arguing it oversteps the state’s authority. Read More