US FDA
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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US FDA publishes Q & A for Development of ANDA During the COVID-19 Pandemic
Guidance can be found at below link. https://www.fda.gov/media/147355/download On April 5, 2021, FDA published a new...
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