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More than 120 questions and answers were added to the European Medicines Agency’s FAQs on the launch of the new EudraVigilance reporting system, set to go live Nov. 22. Read More
Drugmakers in Canada, China, the Philippines and several American states received warning letters for a variety of GMP missteps, and some of the foreign operators were slapped with import bans. Read More
The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More
Facing a drastic loss of revenue and market share to a competing generic drug, Indivior said it will appeal an adverse federal court ruling on its patent for Suboxone (buprenorphine and naloxone), a sublingual film indicated for the maintenance treatment of opioid dependence. Read More
Novo Nordisk will pay more than $58 million for failing to comply with FDA regulations on risk disclosures for its diabetes medication Victoza. Read More
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