FDA

What to expect from the new leadership and why there's not much hope for an improved directive.

Proposals to reduce outlays for drugs could limit biomedical research and product development.

The director of Health Economics and Reimbursement for the Regulatory & Clinical Research Institute (RCRI) discusses the repercussions of implementing ICD-10.

Recent legislative and regulatory changes increase the country's appeal as a destination for research.

What antitrust authorities have uncovered so far in their search for sabotage.

The case for standardizing the use of clinician rated outcome measures to improve research studies.

More resources and new leadership could help FDA regain its stature and bolster support for innovation.

Organizations offering courses and classes designed to broaden your clinical trials knowledge base.

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

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.