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

Hydrocodone Up-scheduling: FDA Faces Philosophical Toss-Up After Advisory Cmte.

Executive Summary

Two-thirds of FDA’s Drug Safety and Risk Management Advisory Committee say the combination products have a similar abuse profile as drugs already on Schedule II, but others note there is no guarantee drug abuse will decline with reclassification, which will adversely affect pain patients’ access to the drugs.

You may also be interested in...



Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint

Prescriber training courses to be provided through continuing medical education venues are to be available by March 1, 2013. Changes from the draft are subtle, but indicate FDA’s focus on preventing incorrect use of the high-dosage narcotics and protecting patients.

Rx Misbranding Penalties Should Be Stronger To Stop Counterfeiting, FDA Says

Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.

Track-And-Trace: With Deadline a Year Away, Some Lessons from Early Adopters

EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.

Topics

UsernamePublicRestriction

Register

LL016481

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