2009, Biosimilars, Licensing and Packaging

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2009

Biosimilars

Licensing

Packaging

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).

FDA

FDA FDA Approval Production Regulations

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

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

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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