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 Packs Need Study Before Mandate, Groups Urge

Executive Summary

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.

You may also be interested in...



Biden Leaves US FDA Largely Out Of Budget Outline

FDA is only mentioned once in the document, and its temporary leadership may not be the reason why.

Opioid Labeling Instructions On Naloxone Are Compromise In Co-Prescribing Debate

US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.

Opioid 'Data Warehouse' Is Part Of US FDA's New Controlled Substances Program

CDER-based program lead by Marta Sokolowska will also handle benzodiazepine and stimulants activities and consult on relevant application assessments.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS140637

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