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Sanofi is planning to shed approximately 900 jobs in France in the lead up to 2015 as it seeks to implement certain key strategic objectives.

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

Johnson & Johnson has announced plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities.

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

The European Medicines Agency has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

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Regulation and Compliance

Q&A on GDUFA implementation with Aloka Srinivasan, PhD, a principal consultant with Parexel and former team leader in FDA's Office of Generic Drugs.

Compliant or Contraband?

International trade can be great for business, but breaking border laws can put one in hot water.