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US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
FDA Encourages Quality by Design Initiatives
FDA Highlights Responsibilities for Finished Biologics Manufacturers
Intellectual Property: Patent or Padlock: Patents and Trade Secrets Form the Heart of an Effective IP Strategy
Legal Forum: Responding to the Avian Flu Threat: Balancing Risks and Rewards
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