Markets & Regulations

Operation Pangea takes another crack at illegal drugs, websites

Operation Pangea takes another crack at illegal drugs, websites

By Zachary Brennan

For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.

Who's on the career ladder?

People on the Move

Who's on the career ladder?

By Fiona BARRY

INC Resarch, SGS and more... All the movers and shakers in pharmaceutical outsourcing in this week's column.

BioOutsource offers inside look at new biosimilar draft guideline

BioOutsource offers inside look at new biosimilar draft guideline

By Zachary Brennan

Outsourcing-Pharma.com reached out to contract testing supplier BioOutsource to see what its take is on biosimilars now that the FDA’s draft guidance on biosimilarity has been released. The following is a lightly edited interview with BioOutsource’s chief...

EU ombudsman takes issue with trial transparency moves by EMA

EU ombudsman takes issue with trial transparency moves by EMA

By Zachary Brennan

In a letter to the EMA (European Medicines Agency), the European Ombudsman Emily O'Reilly has expressed concern that a significant change of policy on trial data transparency could limit the amount of data that becomes available.

US FDA unveils long-awaited biosimilar guidance

US FDA unveils long-awaited biosimilar guidance

By Zachary Brennan

The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.