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

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

Executive Summary

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.

You may also be interested in...



New Supplement Timelines, Categories Proposed For BsUFA III

The ideas could potentially address sponsor concerns about the effects of slow reviews.

New Supplement Timelines, Categories Proposed For BsUFA III

The ideas could potentially address sponsor concerns about the effects of slow reviews.

Tentative Biosimilar Approvals Under Consideration By FDA

Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143668

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