Day: October 29, 2026

The last decade, the FDA has been moving the medical device regulatory submissions to a standardized electronic template, the eSTAR. This electronic template replaces guesswork and streamlines regulatory submissions. With the latest expansion of the eSTAR template, now the Investigational Device Exemption (IDE) applications also can be created using the eSTAR template.  The latest FDA … Read more

The rapid evolution of genome editing technologies has brought us to the threshold of true precision medicine. For patients suffering from monogenic diseases caused by diverse, patient-specific gene variants, standard gene therapies often fall short. Recognizing this gap, the FDA released a new guidance to suggest how sponsors can bundle multiple product variants under a … Read more