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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA revises guidance for industry on generic drug development and application submission during the COVID-19 public health emergency
Today, September 8, 2021, FDA revised the guidance for industry Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, originally published in April 2021. The guidance collects questions the FDA has received from prospective applicants and applicants of abbreviated new drug applications (ANDAs) about generic drug product development and application assessment during the COVID-19 public health emergency and provides formal responses for the benefit of all stakeholders.
The guidance provides general recommendations in the form of questions and answers in topic categories including generic drug product development, ANDA submission and assessment, and marketing and exclusivity. FDA updates this guidance as appropriate, and this revision includes:
- Clarification on when FDA will accept requests to receive an ANDA with less than the full complement of recommended stability data
- Additional information on approaches for when a test product batch used in an interrupted bioequivalence study expires
- Other minor updates to the frequently asked questions
FDA recognizes that the COVID-19 public health emergency may impact the development of generic drug products, interrupt or delay ANDA applicants’ bioequivalence studies, and impact the submission of ANDAs to FDA for assessment. The ongoing development of generic drugs submitted as ANDAs to the FDA for assessment helps Americans continue to have access to safe, effective generic drugs.
Additional Resources
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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