Development of Abbreviated New Drug Applications (ANDAs) During the COVID-19 Pandemic – Questions and Answers

On 5 April 2021 the FDA issued the final Q&A guidance on ANDAs development during COVID-19.

FDA is issuing this guidance to provide 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.

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