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FDA presenter urges submitters to follow guidance and include requalification evidence
Summary
Chen concluded by urging manufacturers to ensure validation and requalification data follow FDA guidance and ISO standards and to include those references and recent studies in ANDA submissions.
In closing, Chen summarized recurring IR causes—excessive or unsupported hold times, missing ISO‑consistent sterilization validation, insufficient requalification, and incomplete media‑fill programs—and advised submitters to check FDA guidance and the cited ISO standards when preparing submissions.
She acknowledged colleagues who helped prepare the presentation and then handed the meeting over to the next presenters, noting reference materials that submitters should consult before filing ANDAs for ophthalmic suspensions.
