If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. On this week’s Business Of Biotech, founder Dr. Robert Hariri discusses the importance of data quality and complete master files for FDA submissions. Listen now and subscribe so you never miss an episode.
“In a sense, the COVID-19 association was a golden opportunity for our drug,” says Rachel Leheny, CEO of CalciMedica, a pharma focused on anti-inflammatories for pancreatitis that has now shifted to treatments for COVID-19 pneumonia.
The FDA treats machine learning and AI in software used by the patient as a medical device (SaMD). If clinical trials are required, then any patent on the software may be entitled to a patent terms extension (PTE) to compensate for the time lost in the clinical testing and regulatory review.
Our in-house editors have informal discussions about some of the hot topics they’re writing about, interesting interviews they’ve had recently with top industry executives, and what they learned during their recent travels to trade shows and conferences.