US FDA
FDA Publishes Draft Guidance on Oral Drug Products Administered Via Enteral Feeding Tube
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled...
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FDA updated its guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19
FDA updated its guidance, Emergency Use Authorization for Vaccines to Prevent COVID-19, to include a new section...
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USFDA publishes guidance for Bispecific Antibody Development Programs
U.S. Food and Drug Administration issued a final guidance, Bispecific Antibody Development Programs. This final guidance provides...
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US FDA issues guidance for ANDAs for Certain Highly Purified Synthetic Peptide Drug Products
On May 19, 2021, the FDA finalized the guidance for industry entitled “ANDAs for Certain Highly...
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FDA Issues Final Guidance on Demonstrating Bioequivalence for Soluble Powder Animal Drugs
On May 20, 2021, the FDA issued final guidance for industry (GFI) #171 entitled “Demonstrating Bioequivalence...
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US FDA updates Q & A guidance on Inspections During COVID-19
FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the...
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US FDA publishes final guidance on ICH Q12
U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12...
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FDA publishes final guidance for BCS Based Biowaivers
On May 11, 2021, the FDA published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based...
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FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
the U.S. Food and Drug Administration issued a new report titled, "Resiliency Roadmap for FDA Inspectional...
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FDA issues guidance on remote evaluation of manufacturing facility during the COVID-19
FDA is issuing this guidance to describe how we will request and conduct voluntary remote interactive...
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