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The Senate HELP Committee on Thursday advanced to the full Senate a bill that would reauthorize FDA user fees through 2022. The vote was 21-2. Read More
A bipartisan bill introduced in the Senate would streamline the clinical trials process and expand patient access to experimental treatments. 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
The European Medicines Agency has expanded the types of documents it will publish alongside clinical study reports from sponsors’ drug product applications. Read More
Trial master files should contain all documents necessary to adequately reconstruct the conduct of a clinical study, along with any decisions made and their justifications, according to European regulations. Read More
The European Medicines Agency published its annual report, listing 81 medicines recommended for approval in 2016, including 27 new active substances. Read More
Scheduling conflicts unrelated to the must-pass FDA user fee reauthorization bill postponed a planned markup Wednesday, but the Senate HELP committee has rescheduled the session for today. Read More