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- FDA updates product-specific guidelines for injectable peptidesThe US Food and Drug Administration (FDA) has updated 17 draft product-specific guidances (PSGs) to assist sponsors in submitting abbreviated new drug applications (ANDAs) for injectable peptide pr…raps · 1d ago↗ source
- Researchers concerned by underutilization of accelerated approval in oncologyMost adult cancer drugs approved by the US Food and Drug Administration (FDA) over the past two decades were regular approvals for expanded indications based on surrogate endpoints, rather than acc…raps · 1d ago↗ source
- FDA unveils FY 2027 user fee ratesThe US Food and Drug Administration (FDA) has published its user fee rates for FY 2027 across its prescription drug, generic drug, biosimilar, medical device, and over-the-counter drug programs. Th…