Pharma R&D Today
Ideas and Insight supporting all stages of Drug Discovery & Development
FDA Announces Plans to Improve Approvals Process for Medical Devices
Posted on January 15th, 2019 by Xuanyan Xu 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.
Pills Have Gone Digital
Posted on November 24th, 2017 by Betsy Davis 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. (more…)
Reducing Adverse Event Risk
Posted on September 25th, 2017 by Sherry Winter 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In 2012, the U.S. Food and Drug Administration (FDA) provided draft guidance for the industry on drug interaction studies, stating that “pharmacokinetic interactions between an investigational new drug and other drugs should be defined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.” (more…)
FDA Speeds Up Generic Approval Process
Posted on August 30th, 2017 by Xuanyan Xu 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.
