FDA
FDA finalizes guidance on prescription drug use-related software
The guidance explains how FDA applies drug labeling authorities to certain software outputs disseminated by or for sponsors for use with prescription drugs and relevant drug-led combination products. It finalizes the September 2023 draft.
Read the official sourceMHRA
Great Britain confirms indefinite recognition of CE marked medical devices
The government confirmed continued recognition of medical devices and IVDs already approved for the EU market, supporting their continued availability in Great Britain.
Read the official sourceMHRA
MHRA publishes consultation outcome on CE marked device recognition
The targeted consultation addressed proposals for recognizing CE marked medical devices in Great Britain.
Read the official sourceMHRA
UK authorization for IXCHIQ withdrawn after safety review
Following advice from the Commission on Human Medicines, MHRA concluded that the chikungunya vaccine’s benefit-risk balance was no longer favorable and withdrew its UK marketing authorization.
Read the official sourceWhy this matters
Regulatory teams now have final FDA direction for certain sponsor-disseminated software outputs used with prescription drugs. In Great Britain, indefinite CE recognition provides a clearer basis for device market access, while the IXCHIQ action underscores how post-authorization safety review can lead to withdrawal when the benefit-risk balance changes.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.