Brian D. Bollwage, JD

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.

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.

Tips for avoiding a clinical hold.

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

Vice President of Global Regulatory Affairs, Theorem Clinical ResearchIntroduction

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.