← Back to the boardHill
FDA announced a draft guidance giving sponsors recommendations for early-phase IND protocols for solid tumor drugs and biologics, with comments due January 11, 2027.
Why it’s here: FDA draft guidance on early-phase IND protocols for solid-tumor drugs and biologics is a federal regulatory action in the biotechnology area, covering novel therapies at the first-in-human stage, though it is a narrow oncology-specific document with limited policy debate.
Trace across the boardItem
3d agoAgencyHealth and Human Services DepartmentFDA announced a draft guidance giving sponsors recommendations for early-phase IND protocols for solid tumor drugs and biologics, with comments due January 11, 2027.BiotechDetails5 linked
Connected
5 links- HillComments due: Early-Phase IND Protocol Recommendations for Solid Tumors; Guidance for Industry - Draft GuidanceBoth involve Food and Drug Administration, Early-Phase IND Protocol Recommendations for Solid Tumors
- HillCRS Report: Novel Gene Therapies for Blood DisordersBoth involve Food and Drug Administration, Center for Biologics Evaluation and Research
- NewsFor peptide enthusiasts, a new HHS policy means party timeBoth involve Food and Drug Administration, Department of Health and Human Services
- NewsBill Cassidy says Trump’s FDA pick faces uncertain committee voteBoth involve Food and Drug Administration, Department of Health and Human Services
- MoneyTranslational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)Both involve Food and Drug Administration, Department of Health and Human Services
About
- Food and Drug Administration
- Center for Biologics Evaluation and Research
- Center for Drug Evaluation and Research
- Department of Health and Human Services