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

Data Integrity and Antibiotic Clinical Trials: FDA, Industry Try Systemic Therapy

This article was originally published in RPM Report

Executive Summary

FDA's push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency's workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance - and those efforts can just as easily be applied to other drug classes

You may also be interested in...



FDA Catching Antibiotic Incentive Bug: Agency Primed To Consider Ways To Shorten Route for Resistant-Strain Drugs

FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process.

Antibiotic Early Endpoints: FDA Looking At Patient Observations

An effort to identify early biomarkers of antibiotic efficacy is turning toward patient assessments of drug activity. FDA and industry scientists are both participating in the biomarker effort. The attention to patient observations reflects a growing interest at FDA.

FDA Catching Antibiotic Incentive Bug: Agency Primed To Consider Ways To Shorten Route for Resistant-Strain Drugs

FDA is working along a parallel path to other several other government agencies to find ways to stimulate drug development for anti-infectives active against resistant strains. Top policy leaders in the drug review divisions reflect the new interest by thinking aloud how historical controls or oncology-like accelerated approvals might speed the process.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS080733

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