FDA
FDA issues temporary neonatal nutrition compounding guidance
FDA published guidance for immediate implementation describing its regulatory and enforcement priorities for compounding certain starter parenteral nutrition drug products for neonates. The action responds to the expected US market exit of the predominant source of these products.
Read the official sourceFDA
FDA seeks comments on HCT/P information collection
FDA opened a 60 day comment opportunity on information collection associated with statutory and regulatory requirements governing certain human cells, tissues, and cellular and tissue based products.
Read the official sourceFDA
FDA proposes pregnancy exposure registry enrollment survey
FDA requested comments on a proposed survey of health care providers intended to advance pregnancy safety data collection and improve health communications.
Read the official sourceFDA
FDA schedules vaccine committee meeting and opens docket
FDA announced a public Vaccines and Related Biological Products Advisory Committee meeting concerning 2027 Southern Hemisphere influenza virus vaccines and established a public comment docket.
Read the official sourceEMA
EMA updates translation review contact points
EMA published version 7.2 of its procedural guideline listing member state contact points for translation review.
Read the official sourceWhy this matters
Regulatory teams should note the immediate neonatal compounding guidance and assess whether the FDA comment opportunities warrant input. The EMA contact list provides an updated procedural reference for translation review coordination.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.