2003, Biosimilars, Packaging and Regulations

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

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

FDA

FDA FDA Approval Regulations Production

Drug Discovery Digest

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

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