FDA To Address Industry Questions About ' Biosimilar Regulations At The Pharma's IQ Immunogenicity Event, 30 May - 1 ...
This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's to discuss FDA directives on Immunogenicity introduced in 2008. Over the last two years, the regulations have been subject interpretation. Although the regulations were released in 2008, there has been some confusion within the Industry as the ...