Remember The Basics: Dosing, Placebo Issues Recur In FDA Reviews
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Fundamental trial design issues, from the selection of doses to the use of placebo controls, recur as problems in FDA reviews of new drugs. Post-market studies can remedy missing data, but at a cost.
You may also be interested in...
FDA’s Regulatory Flexibility On Display In Review Of Innovative Agents
Regulatory flexibility is the backbone of FDA’s success in efficiently reviewing new drugs and biologics, especially on the frontiers of unmet medical needs, Pharmaceutical Approvals Monthly’s 2011 series of drug review profiles shows.
Keeping Track: 2021’s First Novel Approvals Go To HIV And Heart Failure Therapies Opdivo Starts Year With A Bang
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA’s Median Review Time For Novel Drugs Held Steady In 2020
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: