Adjuvants Need Approval Pathway Separate From Vaccines, Industry Tells FDA
Industry is calling on FDA to write separate rules for assessing adjuvants. This would encourage innovation in immunotherapies, the Biotechnology Industry Organization and Pharmaceutical Research and Manufacturers of America contend.
You may also be interested in...
But even though the agency’s final guidance on cancer vaccines adds a section on adjuvants, the additional data requirements that FDA will request remain relatively vague.
House appropriators are pressing FDA to license adjuvanted seasonal influenza vaccines that have a proven safety record.
House oversight committee hears plea for more transparent, predictable regulatory processes at FDA.