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

Opioid Blister Pack Mandate Could Be Phased-In Based On Prescription Volume

Executive Summary

US FDA seeks public input on potential advantages and challenges of requiring 5-, 10, and -15-count blister packs for certain opioids and the idea of staggering implementation.

You may also be interested in...



Opioid Blister Packs Need Study Before Mandate, Groups Urge

AAM, Upsher-Smith, APhA, and Cigna tell US FDA that packaging requirement will increase manufacturing and drug costs, create reimbursement hurdles and reduce access to medicines. Daiichi-Sankyo supports agency's proposal.

New Opioids May Need Comparative Effectiveness Data For Approval

Draft guidance says US FDA will consider product's benefit-risk balance relative to approved analgesics; it is particularly interested in comparative efficacy and safety data.

How To Deal With High Dose Opioids: Better Storage, Disposal And Advertising

Beyond considering removal from the market, US FDA advisory panel suggests actions agency could take to improve the safety of higher dosage strength opioids.

Related Content

Topics

UsernamePublicRestriction

Register

PS125386

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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