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FDA Offers guidance on Generic Drug Development- COVID

Updated: Aug 21, 2021

US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing generic product development and abbreviated new drug application (ANDA) submissions and assessments during the COVID-19 public health emergency.

The immediately effective guidance explains the questions the agency has received from generic drug makers throughout the pandemic.

Guidance: Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. ( Guidance for Industry August 2020)

Updated on January 29, 2021

FDA has issued guidance on how to implement manufacturing process and facility changes; relevant guidances that describe the process for reporting changes to an application can be found in the guidance section V.

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