FDA

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

Interdisciplinary networking, publications, and conferences are a few of the benefits of society membership.

Web sites of interest to the clinical trials professional, including clinical trials listings, FDA and government sites, tools, and popular industry organizations.

A comprehensive listing of U.S. departments and offices that includes the telephone numbers of directors, commissioners, and advisors.

Animal use in clinical trials comes into question as Europe debates an update of current rules.

The work-life benefits offered by the FDA and how it effects the employees overall work experience.

The EU provides extensive funds to the clinical trials industry in an effort to better health care delivery.

From pre- to postmarketing, safety monitoring must be a priority that's handled with knowledgeable care.

FDA is conducting more inspections to ensure that foreign clinical research meets GCP standards.

Shedding light on common EMR concerns about privacy, government regulations, and data integrity.

A perspective on the agency's updated guidance on the use of computer systems in clinical research.

Keeping score of Europe's one-year-old initiative to promote research for the pediatric community.

REMS are new only in name. The basic concept has long been central to drug regulation.

Slowdown in new drugs to market prompts antitrust investigation by EU competition authorities.

Global harmonization, regulatory flexibility promise to expand treatments for rare and neglected diseases.

Detailed charter defines the roles of the group and their relationships with other study team members-and it's available inside as a word document that you can download for use.

From a new guidance on inspections to a bid to help the EU regain its R&D prowess, the Agency is busy.

Comparative drug analysis aims to address costs and value as candidates eye curbs on drug spending.

Chris Bode, PhD, vice president of corporate development for Absorption Systems, explains the impact of in vitro models relative to the Critical Path Initiative.

In the European Union, regulators are agonizing over more than just clinical trials.

Low costs, a rich patient base, and strong talent pool characterize Africa's most populated country.

Survey uncovers current market and future directions for the European clinical trials industry.

How one group is transforming clinical cancer research across all of Europe.

With backing from pharma and high hopes, Eu takes steps to improve front-end approaches to R&D.

Ketek probe raises questions about research oversight by FDA, sponsors, and investigators.