Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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's Pediatric Experts, Not Review Division, Should Have Final Say On Pediatric Trials, Former Official Says

Executive Summary

Former Associate Commissioner Janice Soreth says views of pediatric experts should take precedence over those of division directors regarding pediatric trials.

You may also be interested in...



Pediatric Study Plans For Coronavirus Therapies To Get Trans-Atlantic Streamlining

EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.

Unjustifiable Delays In Generic Competition? Biopharma Contends There Is No Problem

As Congress prepares to again debate patent reforms, brand industry says allegations of ‘patent thickets’ and extended market exclusivity are based on inaccurate or misleading data. They assert there is no need for PTO and FDA to institute systemic policy changes.

Absence Of Braille In Generic Hetlioz Label Merits Its Withdrawal, Vanda Lawsuit Argues

Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141313

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