FDA

Patient safety, orphan medicines featured in EU's six-year research support budget.

Safety issues come under close scrutiny at Amsterdam meeting.

A changing research enterprise requires clearer policies and more effective regulatory tactics.

Along with the titles and phone numbers of personnel, View from Brussels columnist Peter O'Donnell gives an update on the regulatory front in Europe.

This newly updated glossary includes even more terms relevant to clinical trials professionals.

This document from HHS and OHRP provides IRBs with instructions for reviewing trial information listed on Websites.

These translations help make sense of initials commonly used by clinical researchers around the world.

There's plenty to tackle this month, including a debate over efficacy, new ARDS guidelines, and evidence the EMEA is listening.

Under IOM's plan, a "lifecycle approach" to drug evaluation would change FDA's pre- and postapproval policies.

Michael Murphy, President and CEO of Gentris Corporation, answers questions about his company's recent expansion into Japan.

Successful efforts of the organ donation sector could serve as a model for rebuilding public trust.

To realize the goal of the directive, member states need to collaborate and make improvements.

Instructions for evaluating adverse event data and guidelines for taking the proper course of action

There are a number of factors potential subjects need to consider when deciding whether to participate in a clinical trial, including an often overlooked matter that this month's authors examine: taxes.

Confusion over policies governing prisoners points to the need for clear, uniform safeguards for all research.

The group's latest ODM release strengthens global reach and lets researchers define conditions in eCRFs.

A review of Euromed Communications' recently published: Paediatric Clinical Research Manual

A discussion of the recent initiatives for applying advanced technologies in real world settings that have the capability to improve drug research, increase subject safety, and reduce development costs, which takes into account the collaborative efforts among government, academia, industry, and patient groups that are necessary to achieve these goals and translate new technological discoveries into clinical practice.

Favorable cost, research quality, and timeline measures are attractive to overseas sponsors.

Rise in foreign studies requires attention to ethical issues, investigator training.

EMEA gives EU six months to respond to highly technical draft guidance on viral safety of biotech meds.

Less stringent requirements in the European Union result in faster medical device approval times.

A patient's agreement to take part in a clinical trial is a legal contract, which consumer law requires to be expressed in plain language.

EU helps ease ambiguity of reporting process with recent published guidance.

Software vendors can help sponsors ensure clinical trial data are accurate, reliable, and authentic.

Why research in Europe has declined since the implementation of the Clinical Trials Directive.

What the agency requires to support the selection of patient reported outcome instruments.

Agency seeks to calm critics by improving subject protection, while also streamlining research oversight.

Payers seek more comparative drug data from sponsors and independent researchers.

European Medicines Agency adopts new approach to drug development process.