USA – FDA proposes updated medtech RWE guidance
The US Food and Drug Administration (FDA) has updated it’s guidance on how real-world data (RWD) can be used to provide real-world evidence (RWE)...
France – ANSM : Pholcodine : Suspension des autorisations de mise sur le marché...
Les autorisations de mise sur le marché de tous les médicaments à base de pholcodine sont suspendues à compter du 8 septembre 2022, à...
UK – Kidney Cancer UK receives commission from NICE
The charity Kidney Cancer UK has, through its approach to NHS England, secured a commission for the National Institute for Health and Care Excellence...
International – ICH releases M11 guideline proposing harmonized template for trial protocols
The International Council for Harmonisation (ICH) has released a draft guideline which outlines a harmonized template for clinical trial protocols to support consistent reporting...
France – L’ANSM publie les nouvelles règles des bonnes pratiques de préparation
Les nouvelles règles ont été élaborées grâce à un Comité scientifique regroupant pharmaciens hospitaliers, officinaux, inspecteurs et universitaires, ainsi qu’à partir des propositions formulées...
USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...
USA – Industry asks FDA to expand scope of product quality assessment guidance
Stakeholders want the US Food and Drug Administration (FDA) to include biosimilars and other biologics regulated by the Center for Biologics Evaluation and Research...
USA – Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other...
More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in...
Europe – EMA Q&A addresses submission of data elements for raw data pilot
The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical...
USA – FDA draft guidance on controlled correspondence reflects GDUFA III commitments
The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to assist generic drug manufacturers in requesting information from the agency...
