FDA

New report based on findings from a 2006 research project adds up savings using CDISC standards.

Added information to inform treatment decisions may drive up research costs for sponsors.

Five-module architecture organizes massive amounts of information included in a marketing submission.

They're crucial in e-clinical applications, and thanks to new solutions, no longer out of reach for smaller companies.

Release of final Guidance is a step in the right direction for Agency and trials.

Group recommends ways to improve and increase clinical research in new report.

E-solutions are on the rise and gaining favor with FDA, as resistance finally gives way.

When it comes to readability, do as the Feds say and not as they do. Federal agencies may recommend that consent forms be written on a junior high school level, but it's a daunting task even for them.

Policy makers discuss incentives for trials on children and for generic versions of biotech therapies.

Strategies sponsors can employ to ensure vendors are complying with regulations-even when none exist.

Trials are on the rise in the country, where recruitment rates are high but custom procedures can pose a problem.

Lack of regulatory cohesion across member states a source of frustration for many in industry.

Stricter regulations & low costs are attracting more multinationals to the country, but hurdles still exist.

In this Q&A article, Professor Jenny Hewison of the University of Leeds shares her views on improving subject recruitment in the UK.

There's more than meets the eye to the EU's new public-centric initiative to simplify drug safety.

The 2006 Guidance reveals the advantages of using electronic modalities, such as IVR, when collecting patient-reported data.

Regulation will benefit both children & drug development, says EMEA, which has a lot on its plate this year.

Drug safety concerns, unproductive methods, and high costs encourage innovative study designs and collaborative efforts.

The fate of a new bird flu vaccine that provides limited protection rests in the hands of FDA.

Interaction is high on FDA's list of ways to improve the development & review process for technologies.

Interactive voice response systems are a good match for adaptive clinical trials and can help keep investigators in the dark.

Why an electronic document management system is key to getting bought by major pharma.

Regulators and sponsors encourage alternative review models to fit a growing research enterprise.

With today's clinical investigators awash in regulatory burdens, it's high time sponsors provided a lifeboat.

UK report on last year's TGN 1412 trial provides industry with blueprint for improved early clinical studies.