USA – Draft guidance outlines FDA’s testing requirements for tissue containment systems
A new draft guidance from the US Food and Drug Administration (FDA) lists potential non-clinical testing requirements for tissue containment systems used in power...
USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
The US Food and Drug Administration (FDA) released a five-year action plan for accelerating drug development for rare neurodegenerative diseases, such as amyotrophic lateral...
USA – FDA authorizes Pfizer, Moderna vaccines for youngest children
The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as...
USA – Marks eyes gene therapy development pilot, sees uptick in successful RMAT requests
Peter Marks, director of Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), attributes an increase in the...
USA – Cavazzoni: Pandemic-era tools, learnings are here to stay
The US Food and Drug Administration’s (FDA) top drug official said the pandemic has prompted the agency to consider new ways of working going...
USA – FDA withdraws cancer drug approval after finding possible higher death rates
The US Food and Drug Administration has rescinded its approval of TG Therapeutics’ Ukoniq (umbralisib) after a clinical trial found patients on the cancer...
USA – FDA officials reflect on quality maturity model, quality metrics
The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said...
USA – Medtech groups want more time to implement FDA’s QMSR rule
Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international...
USA – FDA issues Q&A on importation of prescription drugs from Canada
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
In final...
USA – Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation
Drugs with blockbuster status and those approved under the US Food and Drug Administration’s (FDA’s) accelerated approval pathway were more likely to receive a...
