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Tag: drug application failures

  • 28 Dec
    Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them

    Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them

    Deficiency letters from the FDA are the most common reason generic drug applications are delayed. Learn the top 5 findings-dissolution issues, impurities, sameness problems, CQAs, and bioequivalence errors-and how to avoid them before submitting your ANDA.
    By: Wellington Osawe 10 Comments Read More

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  • Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them Deficiency Letters in Generic Applications: Common FDA Findings and How to Avoid Them Dec 28 2025
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