FDA Finalises Guidance on Adaptive Trial Designs

The FDA has finalised guidance on adaptive clinical trial designs for drugs and biologics. View

 

FDA Drafts Guidance on Complex Innovative Trial Designs

The FDA has drafted guidance on complex innovative trial designs for drugs and biologics. View

 

FDA Revises Guidance on Post-marketing Studies 

The FDA has revised its draft guidance on post-marketing studies and clinical trials. View

 

FDA Unveils TMAP

The FDA has released its Technology Modernization Action Plan (TMAP) to prepare for the increase in data-rich applications. View

 

FDA Developing Guidelines for RWD Quality

The FDA is developing new guidance on data quality to address the inconsistency of available real-world data (RWD). View article

 

Tightening the Rules for Post-Marketing Studies

What does the FDA require from post-marketing studies and is it enough?

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FDA’s Perspective on the Delivery of Safe, Effective New Medicines

The FDA has outlined its approach on delivering new medicines without compromising on safety and efficacy. View article

 

One Third Pre-Approved Medicines Never Complete Approval Process

A study has shown that a third of drugs approved via the FDA’s accelerated approval pathway never complete the process. View article

 

FDA & EMA Discuss Quality Challenges in Hitting the Fast Lane

A report has been released on the joint FDA and EMA workshop with industry discussing the challenges encountered in fast tracking drug development. View

 

FDA Reviews Framework for Uses of RWD & RWE

The FDA is re-evaluating its framework on the uses of real-world data (RWD) and real-world evidence (RWE) in pre and post-marketing settings. View article

 

FDA Outlines Main Priorities

The FDA has outlined its main priorities including the use of innovative clinical trial designs and real-world evidence to improve the generalizability of evidence to patient populations excluded from traditional clinical trials. View article

 

FDA on Accelerated Approvals and Emerging Trial Designs

The changes in approach the FDA would like to see in clinical trial design. View article

 

FDA Aims to Predict Trial Outcomes Using RWE

The FDA is testing the limits of real-world evidence (RWE) by using it to try to predict the outcomes of trials before they are completed. View article

 

FDA to Revamp Review Framework for Devices Using AI and Machine Learning

The FDA is creating a new regulatory framework for the approval of devices using artificial Intelligence (AI) and machine learning. View article

 

FDA’s OCE Releases Annual Report for 2018

The FDA’s Oncology Center for Excellence (OCE) release their first annual report. View

 

FDA Issues Framework for Real World Evidence Use

The FDA has released its framework for dealing with real-world evidence (RWE). View

 

FDA Updates Guidance on Rare Disease R&D

The FDA has revised its 2015 draft guidance on rare diseases, with updates including the evaluation and validation biomarkers as surrogate endpoints. View