Regulatory Articles

Regulatory Approval in India: An Updated Review

May 04, 2016

By Chirag Shah, Param Dave, MPharm

Issues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.

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.

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."

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