Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Pills Have Gone Digital

Posted on November 24th, 2017 by in Pharma R&D

Paranoiacs and conspiracy theorists beware – the digital pill is here. The U.S. Food and Drug Administration announced on November 13 that it had approved Abilify MyCite (aripiprazole tablets with sensors), the first drug in America to have a digital ingestion tracking system. Continue reading “Pills Have Gone Digital” »

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In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined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.

Continue reading “FDA Speeds Up Generic Approval Process” »

Assessing DDI Risk in the Digital Age

Posted on August 9th, 2017 by in Pharmacovigilance

pills pic for SD case study
In their 2012 Drug Regulations, the U.S. Food and Drug Administration recommended that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined during drug development.”

Continue reading “Assessing DDI Risk in the Digital Age” »

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