USA – Stakeholders want consistency, more examples in last FDA draft guidance on patient-focused...
The last draft guidance on using clinical outcomes assessments (COA) as endpoints in patient-focused drug development (PFDD) should use terminology more consistently, align more...
USA – FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes
Today, the U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for...
USA – FDA finalizes guidance on quantitative efficacy and risk info for DTC promotional...
The US Food and Drug Administration (FDA) has published final guidance on presenting risk and efficacy for direct-to-consumer (DTC) promotional labeling and advertisements for...
USA – FDA grants fast track designation to AC Immune’s Alzheimer’s disease vaccine
The candidate, ACI-24.060, will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate...
USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential...
USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
An industry group representing pharmaceutical and biotechnology companies is asking the US Food and Drug Administration (FDA) not to require the reporting of results...
USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in...
USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne...
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of...
USA – Generic drug lobby details extent of US shortages, offers possible solutions
The Association for Accessible Medicines (AAM) has issued a white paper urging the US Food and Drug Administration (FDA) and other policymakers to adopt...
USA – FDA pilot aims to boost transparency for oncology tests
The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for...
