Addressing the rapidly changing clinical landscape

The Cures Act is part of a broader effort by FDA to improve the regulatory process and speed treatments to those in need.  Dr. Gottlieb published a blog post affirming FDA’s commitment to hiring staff and meeting the goals of HHS Secretary’s Reimagine FDA directive.
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10 pharma and biotech trends to watch in 2018

There is a strong possibility that tech giants, like Amazon and Google, will begin to enter the pharma and biotech field. Industry stakeholders expect that we will see large tech companies starting biotech initiatives because it's considered an attractive investment.
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Artificial Intelligence in Medicine: Hope or Hype?

The application of AI in the medical field holds great promise for improving patient health, but will doctors and patients feel comfortable using it? Young startups have begun leveraging this technology to prove better health outcomes, but there's still a lot to do.
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Best Practices In FDA Orphan Drug Submissions

Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of development efforts.
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