USA – Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program...
USA – FDA updates generic transdermal and topical delivery systems guidances
The US Food and Drug Administration (FDA) on Wednesday issued two revised draft guidances for generic drug submissions that use transdermal and topical delivery...
France – FDA guidance calls for testing all alcohol-based products for methanol
The US Food and Drug Administration (FDA) issued final guidance to assist manufacturers and compounders in testing alcohol products (ethanol and isopropyl) for methanol....
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 – Groups weigh in on FDA’s licensing rules for 3PLs and distributors
Supply chain trading partners expressed broad support for the US Food and Drug Administration’s (FDA) proposed rule on uniform licensing standards for wholesale distributors...
USA – FDA finalizes umbrella trial guidance for cell and gene therapies
The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in...
USA – Provider groups, researchers raise concerns about extrapolating adult data in children
Clinicians and researchers are voicing concerns that the US Food and Drug Administration (FDA) has overemphasized the role for extrapolating adult data in pediatric...
USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA
Pfizer a annoncé vendredi que la Food and Drug Administration (FDA) américaine avait approuvé le Zavzpret, son spray nasal pour le traitement de la...
USA – FDA wants feedback on testing methods for new nitrosamines
The US Food and Drug Administration (FDA) is requesting stakeholder input on approaches for identifying and testing novel nitrosamines identified in drug products and...
USA – FDA offers guidance on fit-for-purpose clinical outcome assessments
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the...
