Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue

Posted on January 17th, 2019 by in Pharma R&D

The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. Continue reading “Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue” »

FDA Announces Plans to Improve Approvals Process for Medical Devices

Posted on January 15th, 2019 by in Pharma R&D

In the pharmaceutical industry, safety protocols are rigorous. Clinical trials, a lengthy and intense part of the drug development process, are deemed absolutely crucial to ensuring the safety and efficacy of new drugs and therapies. There are also many regulations designed to make certain that high standards are maintained during the various trial phases.

Continue reading “FDA Announces Plans to Improve Approvals Process for Medical Devices” »

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In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined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

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