Contact Us

Latest Developments and Insights

Blog Categories
Select Category
Blog Categories

Formal Meetings with FDA for Biosimilar Products

February 10, 2016 | Chip Carnathan, PhD, RAC, Director Regulatory Affairs | Regulatory Affairs, Drug Development Consulting Yeah, yeah, we know. The general public considers biosimilars to be “generic” versions of approved biological products. The FDA has gone to great…

Read Full Article

How to Make Publishing Clinical Summaries Easier

February 4, 2016 | BJ Witkin, Senior Manager | Regulatory Operations One of the biggest challenges of publishing an NDA, MAA or BLA is dealing with the clinical summaries: the Summary of Clinical Safety (SCS), the Summary of Clinical Efficacy…

Read Full Article

Direct-to-Consumer Advertising of Prescription Drugs

August 20, 2015 | Mark Cierpial, PhD, RAC, Chief Executive Officer | Regulatory Affairs We’ve all seen or heard them – either in popular magazines and newspapers or on television and radio – advertisements directed to us, the consumers of…

Read Full Article