Vaccine Biomarkers: Don't Put Cart Before Horse When Designing Studies, US FDA Advises
Executive Summary
If a sponsor wants to use a biomarker to show vaccine effectiveness, it should first explain why a clinical endpoint study is not feasible, US FDA official advises.
You may also be interested in...
Prevnar 13 Post-Market Trials Must Confirm Surrogate Endpoint, Deal With Immunogenicity
New post-marketing commitment will look at conjugate pneumonia vaccine when given in patients 50 and older who have already received Merck’s polysaccharide vaccine.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.