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.

Menu

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
My View
Tags:
Guidance Documents Regulation International

Global Pharma Guidance Tracker – September 2023

  • Data

Executive Summary

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

You may also be interested in...



Global Medtech Guidance Tracker: November 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape

The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.

Qualifying Digital Biomarkers ‘Much Easier Now’ Thanks To EMA Efforts

The European Medicines Agency has been on a steep learning curve with its qualification of a digitally-measured outcome for use in Duchenne muscular dystrophy trials, smoothing the way for other developers entering the digital biomarker space.

Table

View full table

Topics

Tags:
Guidance Documents Regulation International
Latest Headlines

US FDA’s Marks Willing To Accept Gene Therapies Occasionally Not Confirming Benefit

FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label

BIO’s New CEO Is Biotech Industry Veteran With Compelling Family Story, Ready To Take On The IRA

Patient-Focused Listening Sessions For Medicare-Negotiated Drugs: Key Takeaways From Round One

See All
UsernamePublicRestriction

Register

PS148990

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

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