Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

For COVID-Impacted Trials, Investigators Should Practice Remote Assessments Beforehand, US FDA Says

Executive Summary

Agency emphasizes feasibility and consistency when it comes to remote administration of clinician-reported and performance outcome assessments in studies disrupted by the pandemic; latest guidance update also discusses remote site monitoring, as well as alternative procurement and administration of investigational products.

You may also be interested in...



CDER Planning Guidances On Single-Trial Approvals, Real-World Evidence

US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.

Informed Consent: For COVID-Affected Studies, A Handwritten Document May Suffice

Under certain circumstances, potential clinical trial participants may be able to provide informed consent by writing on a blank piece of paper that they voluntarily agree to participate in a given protocol and texting or emailing a photo of the signed document to the investigator, US FDA says in latest guidance update.

US FDA’s Biologics Center May Be Busier After Coronavirus Subsides, Director Says

Peter Marks suggests that cell and gene therapy, as well as other product sponsors will be seeking help with clinical trials stalled by the pandemic.

Related Content

Topics

UsernamePublicRestriction

Register

LL035386

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel