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

Pre-Market Safety Must Balance Statistics With Clinical Discernment – FDA

Executive Summary

The next chapter for drug safety will be to more accurately quantify harm and risk in the pre-market setting, FDA's Office of Biostatistics Director Robert O'Neill said at a recent drug safety conference

You may also be interested in...



FDA Looks To Outcomes Research In Move To Quantify Risk/Benefit Decisions

Outcomes trials appear to hold a strong position in the future of new drug development. But outcomes data is not the only factor FDA will consider as it moves toward setting new standards for quantification of risk and benefit, the agency said at a recent drug safety conference

With Toxicology Databases, FDA & Industry Aim To Use, Not Lose, Safety Data

Both FDA and industry are organizing databases to make the toxicities of known compounds available to the researchers making decisions in early development. Those efforts at computational toxicology are being met with a great deal of excitement

IFRA Hosts Capitol Hill Scent Experience In Timeout From Policy Concerns

The International Fragrance Association North America took a break from its higher-stakes advocacy work Nov. 1 to give lawmakers and congressional staffers a "scent experience." Perfumers from six of the group's biggest members were on hand with "Scents of Home," joined by Monell Center researchers to educate attendees on the mechanics of scent and the important role it plays in people's lives.

Latest News
See All
UsernamePublicRestriction

Register

PS050319

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