The preparations have spanned almost 40 years, and there have been many significant obstacles to overcome. However, the “Unitary Patent” and the dedicated “Unitary P...

The requirement to demonstrate compliance, while still maintaining process efficiency and ease of use for marketing teams and time-to-market for life science compani...

The International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and US Food and Drug Administration (US FDA) have laid out their expectations wi...

It is very difficult to estimate how many mergers and acquisitions in the pharmaceutical industry have succeeded. It is even more difficult to define what success me...

The FDA has finally given some guidance on what drug companies must do to comply with federal reporting requirements when marketing their products through social med...