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

Switch Paradigm Change Sees Long Road, Breeds Questions

This article was originally published in The Tan Sheet

Executive Summary

Industry has opposed establishing an intermediate class of drugs between Rx and OTC, and FDA has held it does not have authority to require firms to allow products to be approved for behind-the-counter access or some other alternative distribution. But the creation of some form of third route to access appears likely.

You may also be interested in...



CDER Talks Switches, Monograph 'More Than Ever,' But Mum On Changes

Officials from FDA's drug center describe their work on the Nonprescription Safe Use Regulatory Expansion initiative and on the center's evaluation of potential solutions to the OTC drug monograph process logjam. A CDER attorneys says FDA" is working towards finalizing" an NSURE regulatory framework.

CDER Talks Switches, Monograph 'More Than Ever,' But Mum On Changes

Officials from FDA's drug center describe their work on the Nonprescription Safe Use Regulatory Expansion initiative and on the center's evaluation of potential solutions to the OTC drug monograph process logjam. A CDER attorneys says FDA" is working towards finalizing" an NSURE regulatory framework.

Rescue Medicine Switch Concept Draws Criticism

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1132542

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