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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
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
AbbVie filed a citizen petition June 3 urging the FDA to establish clear and transparent labeling requirements for biosimilars, saying this will avoid potentially unsafe substitution of the products and their reference products. Read More