> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on ANDA Development During Covid
- URL: https://www.fdaweb.com/guide-on-anda-development-during-covid/
- Published: 2021-04-05T12:00:00.000Z
- Updated: 2026-09-14T16:53:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149039

*C*DER has released a [final guidance](https://www.fda.gov/media/147355/download?ref=fdaweb.com) entitled *Development of Abbreviated New Drug Applications During the Covid-19 Pandemic — Questions and Answers.* The document provides general recommendations to ANDA applicants related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by the agency during the Covid-19 public health emergency. The questions and answers are presented in three categories: (**1**) generic drug product development; (**2**) submission and assessment of ANDAs; and (**3**) marketing and exclusivity.