FDA
FDA seeks comments on channels of trade information collection
FDA opened a 60 day public comment period on the information collection provisions in its guidance covering commodities with pesticide residues after EPA tolerances are revoked, suspended, or modified for dietary risk considerations.
Read the official sourceEMA
EMA publishes Q&A on withdrawn Zinmyleo application
EMA published questions and answers concerning the withdrawal of the marketing authorization application for Zinmyleo (trilaciclib).
Read the official sourceMHRA
MHRA approves catumaxomab
MHRA approved catumaxomab to treat cancer related fluid build up in the abdomen and said it will keep the medicine’s safety and effectiveness under close review.
Read the official sourceMHRA
MHRA updates new manufacturing and wholesale licence list
MHRA published its list of sites granted a manufacturer or wholesale dealer licence.
Read the official sourceMHRA
MHRA updates terminated and cancelled licence list
MHRA published information on UK companies whose licences to manufacture or wholesale medicines were terminated and cancelled.
Read the official sourceWhy this matters
Regulatory teams have an active opportunity to comment on an FDA information collection, alongside new European records affecting authorization intelligence and supply chain verification. The paired UK licence updates are particularly useful for checking current manufacturing and wholesale status.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.