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June 2020
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.
Finalized Draft Guidance Documents:
Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry (Published 30Jun2020)
Review and Update of Device Establishment Inspection Processes and Standards Guidance for Industry (Published 29Jun2020)
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)
Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry (Published 19Jun2020)
Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry (Published 16Jun2020)
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)
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)
New Draft Guidance Documents:
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines (Published 30un2020)
WHO ACT-Accelerator prioritizes global vaccine approach (Published 29Jun2020)
EMA revises methodological guidance for trials impacted by COVID-19 (Published 29Jun2020)
EMA nominates executive director to replace Rasi (Published 25Jun2020)
EMA recommends remdesivir to treat COVID-19, authorization expected next week (Published 25Jun2020)
International regulators iron out COVID vaccine trial harmonization (Published 24Jun2020)
Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals (Published 23Jun2020)
FDA Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials (Published 23Jun2020)
FDA to sponsors: Early communication key during COVID-19 (Published 22Jun2020)
Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers (Published 22Jun2020)
FDA: Follow CDC guidance for COVID-infected employees (Published 19Jun2020)
Biopharma industry urges MRA to mitigate risk of no-deal Brexit (Published 19Jun2020)
FDA officials update on orphan drugs, gene therapies at DIA (Published 18Jun2020)
European Commission proposes relaxing GMO regs for COVID-19 vaccines (Published 18Jun2020)
New accelerator to boost real-world COVID-19 diagnostics (Published 18Jun2020)
BIO: What it takes to make the leap to decentralized trials (Published 16Jun2020)
Regulators discuss accelerated approvals, Project Orbis at DIA (Published 16Jun2020)
Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling (Published 16Jun2020)
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)
How regulators have adapted globally to clinical trials for drugs and biologics during the COVID-19 crisis (Published 15Jun2020)
UPDATED: FDA’s CURE ID app gets COVID-19 refresh (Published 12Jun2020)
EMA management board backs rolling review fees, COVID-19 transparency measures (Published 12Jun2020)
BIO: FDA weighs post-pandemic challenges (Published 11Jun2020)
FDA grants first EUA for COVID next-generation sequencing (Published 11Jun2020)
Experts address clinical challenges for ultra-rare diseases at BIO (Published 11Jun2020)
EU Regulatory Roundup: MHRA puts speed-to-market at center of post-Brexit vision (Published 11Jun2020)
EMA issues guidance on remote GCP inspections (Published 07Jul2020)
Orphan drug incentives reviewed at BIO (Published 09Jun2020)
FDA reports on drug quality, oversight trends in FY2019 (Published 09Jun2020)
FDA names Farley director of the Office of Infectious Diseases (Published 09Jun2020)
WHO drafts recommendations for regulatory reliance (Published 09Jun2020)
Cell and gene therapies: FDA official on COVID-19 impact (Published 08Jun2020)
Drug samples: FDA issues policy on distribution amid COVID-19 (Published 08Jun2020)
E-signatures clarified in FDA’s COVID-19 clinical trial guidance (Published 04Jun2020)
FDA eases IRB review of COVID-19 expanded access requests (Published 03Jun2020)
ICH updates on upcoming guidelines, adds new participants (Published 03Jun2020)
Canada’s drug price reforms delayed to 2021 (Published 02Jun2020)
FDA’s MyStudies app provides platform for electronic informed consent (Published 01Jun2020)
Hahn: FDA will make some changes amid COVID-19 permanent (Published 01Jun2020)
EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication (Published on 01Jun2020)
- Explore the Veristat COVID-19 Resource page
- Download our COVID-19 Guide on Strategie For Success During the COVID-19 Era
- Read our infographic to Understand FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs
- Download the Infographic explaining the Types of FDA Meetings with CDER and CBER
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