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Business & Regulation

Business & Regulation Business Practice

Tackling Serious Organizational Failure

| Peter Calcott

An FDA Warning Letter can be a real wake up call. How can you address the root of the problem?

Business & Regulation Business Practice

Boosting Access to Medicine

Sitting Down With… Wim Leereveld, founder and CEO of the Access to Medicine Foundation

Business & Regulation Business Practice

Facing up to Neglected Diseases

| Faiz Kermani

The World Health Organization has compiled a list of 17 tropical diseases that deserve higher priority.

Business & Regulation Standards & Regulation

Clinical Compromise for Europe

| Markus Hartmann

After years of intense criticism, the European Parliament has adopted a new regulation for clinical trials that will replace the current EU Clinical Trials Directive by mid-2016.

Business & Regulation Biosimilars

Copycat Drug Drama

| Charlotte Barker

Lilly and Sanofi go head-to-head on a diabetes drug. Meanwhile, Hospira sues the FDA over a new generic approval.

Business & Regulation Standards & Regulation

Controversial Shuffle for EC Pharma Policy

| Charlotte Barker

European Commission (EC) plans to transfer governance of the medicines dossier from health to enterprise has upset public health NGOs.

Business & Regulation Standards & Regulation

FDA’s Most Wanted

| Stephanie Vine

Top food and pharma fugitives are named and shamed.

Business & Regulation Business Practice

The Magazine for Medicine Makers

| Charlotte Barker

If you work in the development or manufacture of drugs and biologics – this is your magazine.

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