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FDA Provides New & Revised Product-Specific Guidances

FDA Provides New & Revised Product-Specific Guidances

Mar 30, 2021 | News, Regulatory

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

Mar 25, 2021 | News, Regulatory

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

Mar 24, 2021 | News, Regulatory

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...
FDA Provides Smooth Pathway for COVID-19 Screening Tests

FDA Provides Smooth Pathway for COVID-19 Screening Tests

Mar 19, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...