USA – FDA unveils FY 2025 user fee rates
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2025 across its prescription drug, generic drug, biosimilar,...
USA – FDA finalizes COVID-era guidance on container closure changes
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors in reporting common changes made to glass vials and stoppers,...
Canada – Notice on Health Canada’s proposed changes to the guidance on recognized standards...
About the updates
Health Canada has updated the:
List of recognized standards for medical devices and
Guidance on using standards to support compliance with the Medical...
USA – FDA issues final guidance user fees for combination products
The US Food and Drug Administration (FDA) on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the...
USA – Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder
The opioid epidemic is a serious and complex public health emergency facing the United States. The Agency has already taken significant steps to decrease...
USA – FDA releases draft guidance on use-related risk analysis for combo products
The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...
USA – FDA drafts guidance on essential outputs for drug delivery devices
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
USA – FDA concerned about potential device shortages due to new EtO limits
Rural and vulnerable populations could be placed at risk as the US Environmental Protection Agency (EPA) imposes new limits on the use of ethylene...
USA – FDA issues long-awaited device remanufacturing guidance
The US Food and Drug Administration (FDA) has published its final guidance on the remanufacturing of medical devices, adding a new section on regulatory...
