Regulatory Articles

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.

Califf Sidesteps Drug Pricing Complaints from Senate

Nov 18, 2015

By Jill Wechsler

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Regulatory News

Phase I Death in France: Update

French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.

Commonwealth Informatics Will Work with FDA on Safety Reviews

FDA will provide expert scientific, clinical and statistical input to guide the further enhancement of CCDA to support FDA reviewers in rapidly detecting and investigating safety signals during new drug application (NDA) reviews and post-market pharmacovigilance activities.

EMA Agrees to Autism Biomarkers

The EU-AIMS Longitudinal European Autism Project (LEAP) is combining genetic testing, neuroimaging, cognitive testing and clinical assessments to identify biological risk markers associated with subtypes of autism.

Cancer MoonShot 2020 Targets Drug Development Inefficiencies

Amgen, Celgene, Independence Blue Cross, Bank of America and many more collaborate to deliver immunotherapies more quickly to cancer patients through historic drug development alliance.

EveryClinicalTrial, New Clinical Trial Registration Service

ECT is comprised of two primary services, Protocol+ for the registration of trials and Results Services for the publications of trial results.

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