Brian D. Bollwage, JD


Data Extrapolation to Support Pediatric Labeling

September 21, 2016

The FDA’s objectives regarding pediatric labeling have been misunderstood due to a confusing history on the matter. Data extrapolation can leverage an avenue for providing more comprehensive labeling for pediatric drugs.

Leveraging Regulatory Science to Succeed at CDRH

December 07, 2015

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.

Characteristics of the Successful IND or IDE

September 17, 2015

Tips for avoiding a clinical hold.

Personalized Medicine and Companion Diagnostics

June 29, 2015

The era of personalized medicine is fast approaching and, in many therapeutic areas such as oncology, is already underway.

How Will the FDA and the EU Regulate my Mobile Medical App?

February 27, 2015

Vice President of Global Regulatory Affairs, Theorem Clinical ResearchIntroduction

The 505(b)(2) NDA Leveraging Other People's Data

October 03, 2013

The 505(b)(2) new drug application (NDA) provides a potentially streamlined path for sponsors who have developed improvements to drug products that have previously received FDA approval.