FDA

A probability sampling assessment by FDA takes a look at compliance in the medical device world.

EMEA releases new guideline for studies in PTSD, as new figures depict a lagging EU.

Roundtable participants discuss challenges and successes with early eCTD implementation.

What managers must know and do to overcome regulatory challenges and avoid hiccups.

Agency officials and sponsors anticipate stiffer oversight of research operations and disclosure requirements.

A look into how the European Union is handling the daunting health threats of the swine flu.

Critical comments of the drug evaluation process bring about strong reaction from industry.

Senior Manager of Global Regulatory Affairs for Wyeth discusses the implementation of eCTD and selecting the proper vendor.

Government funding slated to boost studies comparing medications to other treatments.

Changing rules on advanced therapy medicinal products to require more from clinical studies.

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.

Ten-year-old study sets precedent for future collaborative observational studies on drug safety.

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.