Regulatory Articles

Tips to Get to (and through) FDA Approvals Faster

Apr 29, 2016

By Siva Reddy

While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.

Trial Transparency: PR Hype or Added Value?

Jan 25, 2016

By Colin G. Miller

The disruptive influence of data transparency in the status quo of product development may have much longer implications to the healthcare process, and information for patients.

Forum Discusses Continued Challenges with Trial Data Transparency

Jan 15, 2016

By Lisa Henderson

With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.

The Balance Between Data and Diversity

Jan 05, 2016

By Jill Wechsler

Califf tackles the many challenges to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.

Leveraging Regulatory Science to Succeed at CDRH

Dec 07, 2015

By Brian D. Bollwage, JD

CDRH announced its top 10 Regulatory Science Priorities for Fiscal Year 2016, and stated that these priorities are more than a mere philosophical statement of topics of interest; rather, these priorities are expected to influence CDRH intramural funding decisions.

Regulatory News

MHRA Tackles Drug Re-Purposing

The MHRA is seeking input on identifying new uses for an existing drug in another indication, or creating novel combinations and sees it as "an emerging and dynamic field of drug development."

DCRI Study Shows Limited Use of Open Trial Data Platforms

The study authors surmised that the lack of validation studies of initial trial results reflected that one goal of open access is not being met. Further, they believe that the limited use indicates a “failure to get the word out “ to researchers.

Austria's Regulatory Chief Secures Top EMA Job

Dr. Christa Wirthumer-Hoche has been elected as the new chair of the Management Board of the European Medicines Agency (EMA).

lorem ipsum