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

DEA Delays in Scheduling Are Offsetting FDA’s Improved Decision Making

This article was originally published in RPM Report

Executive Summary

FDA is showing a renewed commitment to meeting review deadlines for new molecular entities, but that is not translating into earlier commercial availability for all NMEs. Some products also need a controlled substance scheduling decision from the Drug Enforcement Administration; those actions have become a new regulatory purgatory that can be painful and frustrating.

You may also be interested in...



Merck Suvorexant Scheduled, But DEA Delays Remain an Issue

DEA scheduled Merck’s Belsomra (suvorexant) August 28, only two weeks after its August 13 approval – much faster than the year-long wait for some drugs. But don’t take that to mean that the DEA process is moving faster for new drugs.

Sunovion Sees Advantage For Aptiom As Unscheduled Epilepsy Drug

Dainippon subsidiary plans to launch its next-generation version of carbamazepine in the second half of 2014. Lack of classification as a controlled substance means more direct access to prescribers, company says.

NCE Market Exclusivity: Eisai Targets DEA Scheduling Delays, Pozen Pushes Bill For Combo Products

Eisai citizen petition requests Belviq and Fycompa approval dates coincide with final DEA scheduling; Pozen advocates exclusivity for new combinations of previously approved molecules.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM014079

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