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A House Energy and Commerce Committee report on cybersecurity breaches at HHS blames the FDA for not acting forcefully enough to prevent a known web vulnerability that has been a security concern for the past decade. Read More
AbbVie is launching new attacks on the FDA’s approach to biosimilar labeling, arguing in a letter posted to regulations.gov that the labels have “indefensible” omissions of how biosimilars and brandname biologics differ. Read More
Drugmakers should limit the amount of acetaminophen in pediatric liquid drugs to 160mg/5mL and include a statement highlighting the concentration on the container and labeling to reduce the chance of overdose, the FDA says. Read More
Drugmakers will have to provide more benefit-risk information in common technical documents submitted to the FDA, European Medicines Agency and other regulators, under revised guidance from the International Conference on Harmonisation. Read More
Actavis must remove its generic version of Endo’s noncrush-resistant painkiller Opana from the U.S. market by Oct. 13, a New York federal judge ruled Friday, citing infringement of Opana’s patents. Read More