2003, Biosimilars, Licensing and Vaccine

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

Agency IQ

JUNE 2, 2023

Given the number of approved drugs and biologics on the market that are dispensed on an outpatient basis – and their generic and biosimilar equivalents – the additional workload on FDA’s labeling review staff could be considerable. However, only licensed blood establishments would be required to submit PMI to FDA for approval.”

FDA

FDA FDA Approval Production Regulations

Drug Discovery Digest

Article FDA Thank You FDA unveils long-awaited Patient Medication Information proposed rule

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