CBER Requests Help From Industry for Staff Training Program

CBER is asking biologics manufacturers to allow the center’s regulatory review, compliance and other relevant staff to visit facilities to help them better understand the biologics industry.

Potential sites that staff could visit include packaging facilities, quality control and pathology and toxicology laboratories and regulatory affairs operations. CBER notes that the visits are not intended as a mechanism to inspect or perform a regulatory function.

Facilities that wish to participate should send an electronic request to www.regulations.gov or a written request to the FDA’s Division of Dockets Management (HFA-305).

Read the pre-publication notice here: www.fdanews.com/02-01-16-CBERTrainingProgram.pdf.