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FDA Provides New & Revised Product-Specific Guidances

FDA Provides New & Revised Product-Specific Guidances

The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA’s expectations in regards to clinical studies demonstrating...
LetsGetChecked’s COVID-19 At-Home Test Approved by FDA

LetsGetChecked’s COVID-19 At-Home Test Approved by FDA

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked’s COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...
Merck Granted Label Expansion by FDA for Keytruda

Merck Granted Label Expansion by FDA for Keytruda

Keytruda, Merck’s checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or...