Standards & Regulation

High quality excipients make all the difference to the drug development process. And yet, for years, excipients were often overlooked by the industry.

What are the consequences of allowing patients to purchase cell and gene therapies directly from hospitals?

Blockchain could be one solution to the saleable returns verification aspect of the US’ Drug Supply Chain Security Act.

Scott Gottlieb prepares to leave the FDA after accomplishing much.

Research and development tax reliefs are available for businesses in many countries, but some companies are not taking advantage.

A recently published report shows how the European Commission has protected patients against anticompetitive practices over the last decade.

EU will allow companies to carry out QC testing in the UK after a "no deal" Brexit, at least under certain conditions and for a limited time.

The potential market for complex generics is substantial, but navigating the FDA’s guidance for proving “sameness” is a real minefield...

What did the partial government shutdown mean for the US pharma industry?

Gearing up for 2019, the EMA shares revised guidelines to better protect the environment.