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Industry poured $58.8 billion into pharmaceutical research and development in 2015, an increase of 10.3 percent from 2014, according to PhRMA. Read More
Within the next five years, clinical research organizations foresee specific technologies redefining trial design, but also posing data integrity risks due to minimal FDA guidance. Read More
In response to industry concerns about the FDA’s handling of biosimilar applications, the agency is looking to establish a dedicated biosimilar review unit as part of BsUFA reauthorizations. Read More