CBER Proposed Rule Eases Restrictions on Constituent Materials

Biologics manufacturers could gain some leeway on constituent materials under a rule the FDA has proposed in response to technological advances in development and manufacturing. Current regulations on constituents such as preservatives, diluents, adjuvants, extraneous protein and antibiotics in biological products may be “unnecessarily restrictive,” according to the FDA notice to be published in the March 30 Federal Register. Comments are due June 28.
Drug Industry Daily