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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. These firings will stretch the Centers resources to take on its existing workload, let alone handle thousands of complex and innovative LDTs.

Patient-Centered

Patient-Centered Consulting Government Clinic

Primary Care Digest

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

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