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

US FDA Eyes New Investigational Drug Label Requirements That Bring International Harmonization

Executive Summary

To help reduce medication errors that can harm patients and compromise research results, FDA – pushed by clinical trial sites – looks to exert more control of the labels of investigational drug products.

You may also be interested in...



Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate

Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.

US FDA Lowers Bar for Latest COVID Monoclonal Antibody Authorization

Lilly appeared to benefit from agency’s increased familiarity in treating COVID-19 with these types of biologics. Changing nature of the pandemic and the loss of utility of older antibodies due to the Omicron variant may have also played a role in the data required for latest EUA.

Califf Pledges To Counter Misinformation As He Returns To US FDA Helm

FDA commissioner's commitment to counter misinformation also appears to include pledge to ensure agency is driven by science-based decisions, not politics.

Topics

Related Companies

UsernamePublicRestriction

Register

PS144348

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