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

Rescue Medicine Switch Concept Draws Criticism

This article was originally published in The Tan Sheet

Executive Summary

FDA considers switching some prescription “antidotes” to restricted nonprescription status so consumers who can self-identify their need for the drugs and who previously had a prescription can easily access them during life-threatening events, says CDER Director Janet Woodcock.

You may also be interested in...



Naloxone Switch: Door Opener For Other NDAs That Swing On Consumer Education

Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.

Naloxone Switch: Door Opener For Other NDAs That Swing On Consumer Education

Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.

Naloxone Switch: Door Opener For Other NDAs That Swing On Consumer Education

Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS105658

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