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The FDA wants sponsors of investigational drugs and biologics to use the Logical Observation Identifiers Names and Codes to identify laboratory results from clinical studies in regulatory submissions, and is asking for suggestions on how it might assist firms in adopting the codes. Read More
Devicemakers that want to ensure enough women participate in their clinical trials should set a clear and prespecified goal and stick to it, experts say. Read More
The FDA is asking clinical investigators who sponsor trials to submit many of the elements that a commercial sponsor would include in an investigational new drug application. Read More
The ayes had it with the House Energy & Commerce Committee May 21, with all 51 members voting to pass the latest version of the 21st Century Cures Act. Read More
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
Novartis has filed a complaint in federal court alleging Apotex infringed on its patent by seeking to manufacture, market and sell a generic version of cancer drug Zometa. Read More