Regulatory Guidance Monthly Review - August 2020

August 2020 


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Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA)  that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval.   Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in August 2020.

 

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New FDA Guidance Documents:

 

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Guidance for Industry  (Published 27Aug2020)

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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 (Published 26Aug2020)

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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 (Published 19Aug2020)

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Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c) Guidance for Industry (Published 18Aug2020)

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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 (Published 14Aug2020)

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Male Breast Cancer: Developing Drugs for Treatment Guidance for Industry (Published 12Aug2020)

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Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format Guidance for Industry (Published 10Aug2020)

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BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE Technical Specifications Document (Published 05Aug2020)

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Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry (Published 05Aug2020)

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New Draft Guidance Documents:

 

Principles for Selecting, Developing, Modifying, and Adapting PatientReported Outcome Instruments for Use in Medical Device Evaluation  Draft Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders DRAFT GUIDANCE (Published 31Aug2020)

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Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry DRAFT GUIDANCE (Published 25Aug2020)

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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment Guidance for Industry DRAFT GUIDANCE (Published 17Aug2020)

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Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry DRAFT GUIDANCE (Published 07Aug2020)

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Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines (Published 31Aug2020)

View FDA News Release

 

COVID-19 Update: FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19 (28Aug2020)

View FDA News Release

 

COVID-19 therapeutics tracker (Published 28Aug2020)

Open RAPS Article

 

ICH updates: E14 consultation, Health Canada implements M9 guideline (Published 28Aug2020)

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FDA explains transfer of ownership policy for generics (Published 28Aug2020)

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Rapid standalone COVID antigen test nabs EUA (Published 27Aug2020)

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Updated: FDA delays collection of drug manufacturing volume data (Published 26Aug2020)

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Lawmakers, experts raise questions after convalescent plasma EUA (Published 25Aug2020)

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Study: FDA details high global drug quality (Published 24Aug2020)

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FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic (Published 23Aug2020)

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ANDA consolidation process updated in new MAPP (Published 21Aug2020)

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Health Canada adopts ICH pediatric drug development guidance (Published 20Aug2020)

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EMA goes all-virtual for remainder of 2020 (Published 20Aug2020)

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FDA issues pandemic inspections FAQ guidance (Published 19Aug2020)

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New MAPP details when FDA notifies drugmakers about ARIA studies (Published 17Aug2020)

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Canada extends non-COVID clinical trial review times (Published 17Aug2020)

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FDA requirement updates for EUAs for diagnostics to support COVID-19 pandemic (Published 17Aug2020)

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Euro Roundup: MHRA looks to restart onsite inspections (Published 13Aug2020)

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Device importers' COVID questions answered by FDA (Published 12Aug2020)

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European Commission reviews impact of orphan, pediatric regulations (Published 11Aug2020)

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Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices (Published 07Aug2020)

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EMA addresses risk evaluation, mitigation for nitrosamines (06Aug2020)

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FDA: Most postmarketing requirements, commitments progressing on schedule (Published 06Aug2020)

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Euro Regulatory Roundup: EMA clears mutual recognition partners to co-audit GMP inspectorates (Published 06Aug2020)

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The Canadian application process and alternate pathway for COVID-19‒related clinical trials (Published 04Aug2020)

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FDA Purple Book Database now includes all CBER-, CDER-licensed biological products (Published 03Aug2020)

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