Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Reducing Adverse Event Risk

Posted on September 25th, 2017 by in Pharma R&D

In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development, as part of an adequate assessment of the drug’s safety and effectiveness.” Continue reading “Reducing Adverse Event Risk” »

FDA Speeds Up Generic Approval Process

Posted on August 30th, 2017 by in Pharmacovigilance

Healthcare has been in the spotlight for much of the year so far, as Congress has wrestled with the difficult question of how to make it both better and more affordable.

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FDA Regulations Reform? Risks and Benefit for the Approval Process of New Drugs

Posted on June 2nd, 2017 by in Pharma R&D

Know the rules

Since 1906, the US Food and Drug Administration (FDA) through regulations has been responsible for ensuring the approval of new drugs whose health benefits outweigh the known risks associated with the drug.

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Personalized vs. Precision Medicine

Posted on February 3rd, 2017 by in Pharma R&D

Last year was a year of impetus for precision medicine. Former President Obama’s budget for the 2016 fiscal year included $215 million for the National Institutes of Health (NIH), Continue reading “Personalized vs. Precision Medicine” »