Tuesday 15 June 2021

Development of abbreviated new drug applications (ANDAs) during the COVID-19 pandemic – Q&A


The US FDA has issued a new guidance document titled “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry.”


The guidance provides general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.


To view the document, see: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-abbreviated-new-drug-applications-during-covid-19-pandemic-questions-and-answers


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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