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

Post-Market Monitoring Can Fill Innovative Switch Data Gaps – Consultants

This article was originally published in The Tan Sheet

Executive Summary

Allowing for post-market monitoring would incentivize sponsors to consider switches and generate data that could inform a decision about potential conditions for safe use “without applying potentially burdensome – and possibly unnecessary – conditions upfront,” Pinney Associates health care consultancy says.

You may also be interested in...



FDA Sketches NSURE Novel Switch Initiative In 2012

FDA clarified parameters for novel switches, including protecting innovators from potentially unfair generic competition and stating that a behind-the-counter class is not being considered, but the year ended without clear signals on what could be the potential first novel switch candidate and when FDA expects to propose regulatory changes to facilitate switches under conditions of safe use.

FDA Sketches NSURE Novel Switch Initiative In 2012

FDA clarified parameters for novel switches, including protecting innovators from potentially unfair generic competition and stating that a behind-the-counter class is not being considered, but the year ended without clear signals on what could be the potential first novel switch candidate and when FDA expects to propose regulatory changes to facilitate switches under conditions of safe use.

European OTC Switch Still Muted By Regulatory Resistance

OTC sales growth is stifled by the EU’s “extremely restricted” switch evaluation process, says AESGP Director General Hubertus Cranz. But while prescription revenues shrink as governments tighten budgets, the OTC market is not hampered in this way.

Related Content

Topics

UsernamePublicRestriction

Register

PS105794

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