Regulatory Guidance Monthly Review - June 2020

June 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 June 2020.

 

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Finalized Draft Guidance Documents:

 

Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry (Published 30Jun2020)

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Review and Update of Device Establishment Inspection Processes and Standards Guidance for Industry (Published 29Jun2020)

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Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers Guidance for Industry and Food and Drug Administration Staff (Published 22Jun2020)

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Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry (Published 19Jun2020)

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Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry (Published 16Jun2020)

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Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency Guidance for Industry (Published 08Jun2020)

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Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators (Published 02Jun2020)

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New Draft Guidance Documents:

 

 

Development of Anti-Infective Drug Products for the Pediatric Population Guidance for Industry DRAFT GUIDANCE

Download DRAFT Guidance

 

 


 

Blog Image-Regulatory Guidanc eMonthly_Regulatory Agencies in the News

 

Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines (Published 30un2020)

View FDA News Release

 

WHO ACT-Accelerator prioritizes global vaccine approach (Published 29Jun2020)

View RAPS Article

 

EMA revises methodological guidance for trials impacted by COVID-19 (Published 29Jun2020)

View RAPS Article

 

EMA nominates executive director to replace Rasi (Published 25Jun2020)

View RAPS Article

 

EMA recommends remdesivir to treat COVID-19, authorization expected next week (Published 25Jun2020)

View RAPS Article

 

International regulators iron out COVID vaccine trial harmonization (Published 24Jun2020)

View RAPS Article

 

Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals (Published 23Jun2020)

View RAPS Article

 

FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials (Published 23Jun2020)

View FDA News Release

 

FDA to sponsors: Early communication key during COVID-19 (Published 22Jun2020)

View RAPS Article

 

Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers (Published 22Jun2020)

View RAPS Article

 

FDA: Follow CDC guidance for COVID-infected employees (Published 19Jun2020)

View RAPS Article

 

Biopharma industry urges MRA to mitigate risk of no-deal Brexit (Published 19Jun2020)

View RAPS Article

 

FDA officials update on orphan drugs, gene therapies at DIA (Published 18Jun2020)

View RAPS Article

 

European Commission proposes relaxing GMO regs for COVID-19 vaccines (Published 18Jun2020)

View RAPS Article

 

New accelerator to boost real-world COVID-19 diagnostics (Published 18Jun2020)

View RAPS Article

 

BIO: What it takes to make the leap to decentralized trials (Published 16Jun2020)

View RAPS Article

 

Regulators discuss accelerated approvals, Project Orbis at DIA (Published 16Jun2020)

View RAPS Article

 

Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling (Published 16Jun2020)

View FDA News Release

 

Coronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use (Published 15Jun2020)

View FDA News Release

 

How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis (Published 15Jun2020)

View FDA News Release

 

UPDATED: FDA’s CURE ID app gets COVID-19 refresh (Published 12Jun2020)

View RAPS Article

 

EMA management board backs rolling review fees, COVID-19 transparency measures (Published 12Jun2020)

View RAPS Article

 

BIO: FDA weighs post-pandemic challenges (Published 11Jun2020)

View RAPS Article

 

FDA grants first EUA for COVID next-generation sequencing (Published 11Jun2020)

View RAPS Article

 

Experts address clinical challenges for ultra-rare diseases at BIO (Published 11Jun2020)

View RAPS Article

 

EU Regulatory Roundup: MHRA puts speed-to-market at center of post-Brexit vision (Published 11Jun2020)

View RAPS Article

 

EMA issues guidance on remote GCP inspections (Published 07Jul2020)

View RAPS Article

 

Orphan drug incentives reviewed at BIO (Published 09Jun2020)

View RAPS Article

 

FDA reports on drug quality, oversight trends in FY2019 (Published 09Jun2020)

View RAPS Article

 

FDA names Farley director of the Office of Infectious Diseases (Published 09Jun2020)

View RAPS Article

 

WHO drafts recommendations for regulatory reliance (Published 09Jun2020)

View RAPS Article

 

Cell and gene therapies: FDA official on COVID-19 impact (Published 08Jun2020)

View RAPS Article

 

Drug samples: FDA issues policy on distribution amid COVID-19 (Published 08Jun2020)

View RAPS Article

 

E-signatures clarified in FDA’s COVID-19 clinical trial guidance (Published 04Jun2020)

View RAPS Article

 

FDA eases IRB review of COVID-19 expanded access requests (Published 03Jun2020)

View RAPS Article

 

ICH updates on upcoming guidelines, adds new participants (Published 03Jun2020)

View RAPS Article

 

Canada’s drug price reforms delayed to 2021 (Published 02Jun2020)

View RAPS Article

 

FDA’s MyStudies app provides platform for electronic informed consent (Published 01Jun2020)

View RAPS Article

 

Hahn: FDA will make some changes amid COVID-19 permanent (Published 01Jun2020)

View RAPS Article

 

EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication (Published on 01Jun2020)

View RAPS Article

 


 

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