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Comparability of Alternative Analytical Procedures

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January 31, 2024 No Comments

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Guidance-Benefit-Risk Assessment for New Drug and Biological Products

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January 30, 2024 No Comments

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Guidenace-ANDA Submissions—Amendments and Requests for Final Approval to Tentatively Approved ANDAs

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January 29, 2024 No Comments

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Guideline for Implementation of GDP Principles at wholesale distributors

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January 28, 2024 No Comments

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Guide on Analytical Instrument Qualification and System Validation (AIQSV)

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January 22, 2024 No Comments

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Guidance on the Responsible Person

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January 21, 2024 No Comments

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Guidance to review a Batch Record

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January 20, 2024 2 Comments

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Guidance on Quality Considerations for Ophthalmic Drug Products

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January 19, 2024 No Comments

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Inspection of Injectable Products for Visible Particulates-Guidance

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January 18, 2024 2 Comments

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Guideline on Specific Adverse Reaction Follow-up 4 questionnaires (Specific AR FUQ)

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January 17, 2024 No Comments