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The FDA cited a drug outsourcing facility in Bethlehem, Penn., for numerous compliance problems including inadequate computer security and lax labeling practices. Read More
The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency. Read More
The European Medicines Agency and the European Network for Health Technology Assessment released a joint work plan to help medicine developers improve clinical research and become more efficient in generating the evidence needed for both agencies. Read More
The PTO’s Patent Trial and Appeal Board issued a final rule clarifying when attorney-client privilege is recognized during the inter partes review process — as well as which communications are protected when seeking patents at the PTO or at foreign intellectual property offices. Read More
Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating drug laws via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Read More