FDA

Additional testing and monitoring requirements promise many changes for pharma R&D.

Until adaptive trials are the norm, industry needs to proceed with care and an iterative approach.

What Canada, the EU, and United States are doing to update their compassionate use regulations.

Journal editors and legislators expand the scope of clinical trial registration and results disclosure.

After a long and winding journey, now the real work begins on the EU Regulation for all those involved.

Who better to educate a wary public about clinical research than the industry's own?

New to the trials scene, many up-and-coming European firms are seeking the expertise of CROs they can trust.

New regulation provides the EU with a solid framework to stimulate R&D for children's medicines.

High-quality programs needed to protect subjects, improve data, harmonize global trials, and manage costs.

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.