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GlaxoSmithKline has asked the U.S. Supreme Court to rule on the proper jurisdiction for a suit over birth defects and its antidepressant Paxil. Read More
The Maryland state legislature has approved a bill to ban excessive price increases for generics and off-patent drugs, and is sending it to the state’s governor for final approval. Read More
The European Medicines Agency published a draft proposal to accept measurements of fibrinogen as a biomarker to identify chronic obstructive pulmonary disease patients for inclusion in clinical trials. Read More
Scott Gottlieb was grilled by a Senate panel over his support for the FDA’s approval standards, as well as his willingness to stand up to his future boss, President Trump. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The FDA provides all the GCP regulations and guidances you need to run a clinical trial, but those documents can’t answer every question you may have. Fortunately, the agency offers another resource — the staff of its Office of Good Clinical Practices. Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Read More