Special Interest
Guidances/Information
|
Date Posted
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Principles for Selecting,
Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for
Use in Medical Device Evaluation: Draft Guidance for Industry and Food and
Drug Administration Staff, And Other Stakeholders - Draft
Guidance
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31 August 2020
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CVM GFI #191 Changes to
Approved NADAs - New NADAs vs. Category II Supplemental NADAs - Final
Guidance
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27 August 2020
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Revised Recommendations
for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products: Guidance for Industry - Final
Guidance
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27 August 2020
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Recommendations to Reduce
the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and Blood Components: Guidance for
Industry - Final Guidance
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26 August 2020
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Evaluating Cancer Drugs in
Patients with Central Nervous System Metastases: Draft Guidance for Industry - Draft
Guidance
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25 August 2020
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Manufacturing, Supply
Chain, and Drug and Biological Product Inspections During COVID-19 Public
Health Emergency Questions and Answers: Guidance for Industry - Final
Guidance
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19 August 2020
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Compliance Policy for the
Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR
320.38(c) : Guidance for Industry - Final Guidance
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18 August 2020
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Acute Myeloid Leukemia:
Developing Drugs and Biological Products for Treatment: Draft Guidance for
Industry - Draft Guidance
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17 August 2020
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Conventional Foley
Catheters - Performance Criteria for Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug Administration Staff - Final
Guidance
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14 August 2020
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Cutaneous Electrodes for
Recording Purposes - Performance Criteria for Safety and Performance Based
Pathway: Guidance for Industry and Food and Drug Administration Staff - Final
Guidance
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14 August 2020
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Civil Money Penalties
Relating to the ClinicalTrials.gov Data Bank: Guidance for Responsible
Parties, Submitters of Certain Applications and Submissions to FDA, and FDA
Staff - Final Guidance
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14 August 2020
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Male Breast Cancer:
Developing Drugs for Treatment: Guidance for Industry - Final
Guidance
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12 August 2020
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Marketing Status
Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ActMarketing Status
Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act - Final
Guidance
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10 August 2020
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Drug-Drug Interaction
Assessment for Therapeutic Proteins Guidance for Industry: Draft Guidance for
Industry - Draft Guidance
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07 August 2020
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Bioresearch monitoring
technical conformance guide - Final Guidance
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05 August 2020
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Limited Population Pathway
for Antibacterial and Antifungal Drugs Guidance for Industry - Final
Guidance
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05 August 2020
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Guidance for Industry:
Action Level for Inorganic Arsenic in Rice Cereals for Infants - Final
Guidance
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04 August 2020
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CPG Sec. 280.100 -
Stability Requirements - Licensed In Vitro Diagnostic Products - Final
Guidance
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31 Jul 2020
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CPG Sec. 280.110-
Microbiological Control Requirements-Licensed Anti-Human Globulin and Blood
Grouping Reagents - Final Guidance
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31 Jul 2020
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