Questions and Answers: Qualification of Digital Technology-based Methodologies to Support Approval of Medicinal Products
On 1 June 2020 the EMA updated the Q&A document on the successful qualification of digital technology-based methodologies intended to support approval of medicinal products.
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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
On 2 June 2020 the FDA announced the availability of this guidance for IRBs and clinical investigators.
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Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)
On 5 June 2020 the FDA announced the availability of this guidance for industry and FDA administration staff.
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FDA / EMA Common Commentary on Submitting an initial Pediatric Study Plan (iPSP) and Paediatric Investigation Plan (PIP) for the Prevention and Treatment of COVID-19
On 2 June 2020 the EMA and FDA published the joint document for medicine developers planning to submit an iPSP and PIP.
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Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency
On 8 June 2020 the FDA announced the availability of this guidance for industry.
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