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As the FDA makes plans for its GDUFA-mandated fiscal 2017 Regulatory Science Plan, industry trade groups are pushing the agency to spend more time communicating its intentions. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
China has released details of a pilot program that extends drug product licensing to domestic research and development institutions and their personnel. Read More
The patent dispute over Janssen’s Remicade continues to balloon, with the drugmaker suing GE Healthcare subsidiary HyClone Laboratories over the use of cell cultures to grow a biosimilar of the drug. Read More
A new study of oncology approvals shows a majority of the candidates approved under accelerated review with surrogate endpoints lacked validation. Read More
Drugmakers submitting ANDAs for products using transdermal delivery systems are expected to demonstrate that they made “reasonable efforts” to optimize the adhesive characteristics of their patches, the FDA says. Read More
As pharmacy benefit managers’ exclusion lists grow longer, drug developers hoping to avoid exclusion must scramble to demonstrate the clinical superiority and cost-effectiveness of their products, according to a new report. Read More
Clinical research organizations foresee specific technologies redefining trial design, but also posing data integrity risks due to minimal FDA guidance. Read More