The Food and Drug Administration announced an
upcoming webinar to provide blood establishments and other stakeholders with an overview of the Office of Blood Research and Review’s (OBRR) approach to the review of biologics license applications (BLAs) for the manufacture of blood and blood components, including source plasma. The webinar will take place 9 a.m. – 2 p.m. ET on Feb. 19.
The
program will feature presentations by OBRR experts including an overview of regulatory requirements, the submission and review process for BLAs, inspection processes and expectations, donation testing, donor-related policies and facility registration. Speakers will also review responses to commonly asked questions.
The event will conclude with a question-and-answer session addressing pre-submitted questions. AABB invites members to email
regulatory@aabb.org with questions that they would like AABB to submit to FDA in advance of the webinar. Community members may also submit questions
directly to FDA by Friday, Jan. 17.
The webinar is free and open to the public, with
registration available through Jan. 17. A recording and materials will be shared after the event.
