Outsourcing-Pharma.com: Holistic Approach Benefits Drug Development

A clinical hold from the U.S. Food and Drug Administration can significantly prolong the time and increase the cost of drug development, which is particularly concerning for emerging/small biotech and specialty pharma companies. In thisRead more

Between 2010 and 2018, 33.8 percent of the 402 orphan indications approved by the FDA were approved for children only or targeted pediatric diseases.[1] The rare pediatric disease priority review voucher program is one incentiveRead more

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drugRead more

With the emergence of the COVID-19 pandemic, we are all experiencing uncertainty. This uncertainty is impacting our personal lives, and it’s also impacting and reshaping the critical research biotech and specialty pharma companies are conducting.Read more

In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlight specific and necessary actionable considerations that directly address key FDARead more