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Showing 49–64 of 155 results

  • FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions:  The Q-Submission Program

    FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

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  • FDA Guidance: Safety of Nanomaterials in Cosmetic Products

    FDA Guidance: Safety of Nanomaterials in Cosmetic Products

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  • FDA Guidance: Types of Communication During the Review of Medical Device Submission (2014)

    FDA Guidance: Types of Communication During the Review of Medical Device Submission (2014)

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  • FDA: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

    FDA: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

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  • FDA: Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

    FDA: Post-marketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

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  • FRAMEWORK FOR PRIORITY IN THE REGISTRATION, POST-REGISTRATION AND PRIOR CONSENT IN DRUG CLINICAL RESEARCH

    FRAMEWORK FOR PRIORITY IN THE REGISTRATION, POST-REGISTRATION AND PRIOR CONSENT IN DRUG CLINICAL RESEARCH

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  • GENERAL REQUIREMENTS FOR PRODUCT CERTIFICATION (RGCP)

    GENERAL REQUIREMENTS FOR PRODUCT CERTIFICATION (RGCP)

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  • GENERAL RULES FOR GRADE 1 AND GRADE 2 PERSONAL HYGIENE PRODUCTS, COSMETICS AND PERFUMES, MANUFACTURED IN BRAZIL AND INTENDED EXCLUSIVELY FOR EXPORT

    GENERAL RULES FOR GRADE 1 AND GRADE 2 PERSONAL HYGIENE PRODUCTS, COSMETICS AND PERFUMES, MANUFACTURED IN BRAZIL AND INTENDED EXCLUSIVELY FOR EXPORT

    $10.00
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  • GOOD MANUFACTURING PRACTICES FOR EXPERIMENTAL DRUGS USED IN CLINICAL TRIALS

    GOOD MANUFACTURING PRACTICES FOR EXPERIMENTAL DRUGS USED IN CLINICAL TRIALS

    $150.00
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  • GOOD MANUFACTURING PRACTICES OF FOOD PRODUCING/INDUSTRIALIZER ESTABLISHMENTS

    GOOD MANUFACTURING PRACTICES OF FOOD PRODUCING/INDUSTRIALIZER ESTABLISHMENTS

    $200.00
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  • GOOD MANUFACTURING PRACTICES OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC PRODUCTS FOR IMPORTERS, DISTRIBUTORS, AND STORAGE COMPANIES

    GOOD MANUFACTURING PRACTICES OF MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC PRODUCTS FOR IMPORTERS, DISTRIBUTORS, AND STORAGE COMPANIES

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  • Guidance for Eval of (AI) Assisted Systems

    Guidance for Eval of (AI) Assisted Systems

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  • Guideline for Comparing the Same Variety of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)

    Guideline for Comparing the Same Variety of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)

    $150.00
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  • INSPECTION PROCESSES AND REQUIREMENTS TO VERIFY THE GOOD MANUFACTURING PRACTICES OF MANUFACTURERS OF ACTIVE PHARMACEUTICAL INGREDIENTS, HEALTH PRODUCTS OF RISK CLASS III AND IV AND MEDICINES

    INSPECTION PROCESSES AND REQUIREMENTS TO VERIFY THE GOOD MANUFACTURING PRACTICES OF MANUFACTURERS OF ACTIVE PHARMACEUTICAL INGREDIENTS, HEALTH PRODUCTS OF RISK CLASS III AND IV AND MEDICINES

    $400.00
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  • INSPECTION PROGRAMS AND ADMINISTRATIVE PROCEDURES TO GRANT OF GOOD MANUFACTURING PRACTICES CERTIFICATE TO MANUFACTURERS OF MEDICAL DEVICES LOCATED OUTSIDE THE BRAZILIAN TERRITORY AND MERCOSUR

    INSPECTION PROGRAMS AND ADMINISTRATIVE PROCEDURES TO GRANT OF GOOD MANUFACTURING PRACTICES CERTIFICATE TO MANUFACTURERS OF MEDICAL DEVICES LOCATED OUTSIDE THE BRAZILIAN TERRITORY AND MERCOSUR

    $30.00
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  • Japan PMDA (PFSB-ELD No. 0928010) : Basic Principles of Global Clinical Trials in Japan

    Japan PMDA (PFSB-ELD No. 0928010) : Basic Principles of Global Clinical Trials in Japan

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