FDA

Why knowing a drug's risk and preparing for a risk evaluation mitigation strategy early on will considerably benefit a drug's development.

The region and its regulatory agencies try to keep up with the rapidly growing clinical trials market.

Stiffer enforcement of research standards aims to restore the public's confidence in agency actions.

The EU struggles to get over its regulatory hurdles in an effort to further R&D success.

The globalization of clinical research leads both sides of the Atlantic to collaborate on GCP inspections.

International health crises expand testing of new vaccines and drug treatments for third-world diseases.

Guidance for the design and conduct of international bioequivalence trials.

Taking advantage of the eCTD's cross-application feature, linking from NDA back to IND.

Pressure to reduce health care spending puts R&D, costs, and coverage on the negotiating table.

Understanding common myths and truths surrounding one of the fastest growing clinical trial markets.

A look at the Pocket Guide to the EU Directives for Clinical Research, published by the Institute of Clinical Research.

Out of the horrors of World War II came the Nuremberg Code, the prototype for human research protection.

European Union health ministers begin reviewing proposals to better adverse event assessment in Europe.

Inside the Medicines for Children Research Network and its work to improve medicines for the young.

FDA leaders stress innovation and disclosure in promoting the agency's public health mission.

Jill Wechsler provides a special report of a briefing with FDA's new commissioner Margaret Hamburg.

Session poses the question can we do better?

How FDA is responding to the demands of a global world, where agency-regulated products are in the trillions.

A current look at FDA's role in electronic medical records.

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.