Day: November 14, 2024

Designing non-clinical toxicity studies is challenging for any new product due to several guidance documents providing seemingly similar but different perspectives on regulatory requirements. This week the FDA released a guidance document describing strategies for non-clinical study plans for oligonucleotide products. More than 20 guidance documents describe the non-clinical study requirements for all drugs and … Read more

Patients trust their doctors for medical information. Previously it has been argued that the rampant misinformation on the internet about medical topics can be countered by patients conferring with their doctors. But what happens when that very source, the doctor, spreads misinformation? Do the medical boards, whose job is to regulate the medical profession, penalize … Read more