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


Hypertension Drug Development To Be Streamlined Under US FDA Guidance

Executive Summary

Sponsors will need fewer dosage comparisons in factorial studies of fixed-dose hypertension combination products under the draft guidance.

You may also be interested in...

Fixed-Combination Hypertension Drugs Get Clearer Regulatory Pathway, But Will Pharma Follow?

Significant effects are expected to be observed on both systolic and diastolic blood pressures, US FDA final guidance says in lone substantive change from  January draft aimed at streamlining development for multi-drug combinations of previously approved products; with only five such products in the clinical pipeline according to Biomedtracker data, there appears to be little big pharma interest in this space.

Disease-Specific Drug Development Guidances Coming From US FDA In 2018

Alzheimer's disease, amyotrophic lateral sclerosis, migraine, and opioid dependence are among conditions that will get drug development guides from FDA; other guidances will address ANDA bioequivalence studies, shared REMS, and continuous manufacturing.

FDA's Gottlieb Pushing 'Seamless' Clinical Trials For Faster Development

US FDA Commissioner notes that combined-phase clinical trials could be expanded beyond oncology as one way of reducing drug development costs.


Related Companies

Latest Headlines
See All



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