FDA

Shire Pharmaceuticals' Carol Rutkowski explains the benefits of training employees in regard to the regulatory eCTD submissions world.

Hear about the benefits of bringing in an objective outsider when implementing an eCTD software.

Best practices for selecting a central lab partner in this popular trial destination.

Biomedical research community finds privacy policies add cost and complexity to clinical studies.

As EU debates plans for advancing R&D in rare diseases, industry assesses the risks and benefits.

New leadership and more resources aim to modernize FDA operations.

Because PKI digital signatures are standards based, electronic records can actually be retained for decades.

A European perspective on the challenges of paper files and the value of its replacement.

Reformers seek disclosure of investigator payments and conflicts of interest.

The stimulus bill expands the health care safety net while boosting investment in health IT and comparative research.

An opinion from Leah Kleylein, a principal consultant for product management, on the technicalities of publishing a regulatory submission.

Exploring the impact of European regulatory changes on the differences in medical device development and approval between the EU and the US.

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.

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

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.