Home » CBER Proposed Rule Eases Restrictions on Constituent Materials
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
Drug Industry Daily
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