The clinical research industry is falling behind the innovation curve, says Ken Getz, executive director of the Tufts Center for the Study of Drug Development (CSDD), taking years — and…

Over the past week, the FDA issued a notice of Abbott’s withdrawal of Cylert NDA, draft guidance on generally accepted scientific knowledge and final guidance on covariates in randomized clinical…

The FDA issued four guidance documents on Thursday covering a variety of topics, including efficacy endpoints for antidiabetic drugs, adjusting for covariates in randomized clinical trials, electronic submission of study…

A medical school research team and a digital therapeutics firm in South Korea used deep learning (DL) models to detect and assess autism in videos of children as young as…

The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review…

Integra LifeSciences has initiated a voluntary recall of all its products manufactured at its Boston facility for the past five years after discovering, through an internal investigation, that the products…

This month, our review of recent clinical trial results features a drug for anemia due to chronic kidney disease that saw success after an FDA complete response letter, positive results…

A New Jersey federal judge has ruled that Mylan cannot pursue a generic version of Janssen Pharmaceuticals’ injectable schizophrenia drug, Invega Trinza. Source: Drug Industry Daily

India-based drugmaker Champaklal Maganlal Homeo Pharmacy (CMHP) has drawn two FDA warning letters in recent weeks over untested glycerin in gastrointestinal products for children, among other serious current good manufacturing…

The FDA has spelled out when drugmakers may use generally accepted scientific knowledge (GASK) to support a drug or biologic application, in a new draft guidance. Source: Drug Industry Daily