FDA
FDA issues draft guidance for early phase solid tumor trials
The draft provides recommendations for early phase IND protocols involving first in human studies or drugs and biologics with limited human experience. It applies to solid tumors and excludes hematologic malignancies.
Read the official sourceFDA
FDA seeks input on patient level data supporting RWE submissions
The agency requested perspectives and innovative solutions addressing access to patient level data when real world data analyzed in clinical studies are included in drug and biological product marketing applications.
Read the official sourceFDA
FDA proposes reclassifying certain oncology IHC test systems
FDA proposed moving specified immunohistochemistry test systems used with corresponding approved oncology therapies from class III premarket approval to class II special controls, subject to premarket notification.
Read the official sourceMHRA
MHRA approves retifanlimab for advanced anal cancer
MHRA approved retifanlimab (ZYNYZ) for adults with squamous cell carcinoma of the anal canal.
Read the official sourceMHRA
MHRA reports carton strength error for combination tablets
Star Pharmaceuticals informed MHRA that certain enalapril maleate and hydrochlorothiazide cartons incorrectly state the hydrochlorothiazide strength as “12. mg” instead of “12.5 mg.”
Read the official sourceWhy this matters
The FDA actions give regulatory teams new material to assess across oncology protocol design, RWE submission practices, and the potential pathway for certain therapy linked diagnostics. The MHRA updates add a new UK oncology approval and a specific packaging defect for market surveillance teams to note.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.