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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.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.