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You are here: Home / Uncategorized / AMCP Seeks Comments for New FDA Biologics Guidance Documents

AMCP Seeks Comments for New FDA Biologics Guidance Documents

The Academy of Managed Care Pharmacy (AMCP) is asking members to submit their input on two new guidance documents released by the Food and Drug Administration on biologics and biosimilars.

The FDA released the following documents:

  • Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers
  • The “Deemed To Be a License” Provision of the BPCI Act

AMCP says the deadline for membership feedback is April 1. Comments should be emailed to advocacy@amcp.org.

To learn more about AMCP, click here.



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