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

AMR Threat Prompts EU, US And Japan To Join Forces To Align Data Requirements For New Drug Developers

Executive Summary

EU, US and Japanese regulatory agencies will provide advice to developers of antibiotics that is consistent with the agreements they have reached on aligning their data requirements.

You may also be interested in...



Increase In Antibacterial R&D Prompts EMA Proposal For Improved Guidance

Following a resurgence of activity in the field of antibacterial products, the European Medicines Agency has proposed merging and updating its two existing guidelines on this topic into a single, clearer, core document.

EU, US, Japan Further Align Clinical Trial Requirements For Certain New Antibiotics

To support the development of antibiotics, regulators from the EU, the US and Japan met for the third time in two years and agreed to further align their clinical trial requirements to study the effects of new drugs in certain indications. The initiative was launched in response to increasing global concerns over antimicrobial resistance and the lack of development of new antibiotics.

Antibiotic Spring? Regulatory Incentives Spur Activity – And Maybe Medical Advances

Regulatory incentives have been successful at attracting developers to antibiotic R&D, but significant medical advances have stubbornly remained rare. Now the pipeline has produced the first novel antibiotic to receive breakthrough status from US FDA and some Phase III trials are raising the efficacy bar to superiority.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS120857

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