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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
Following the FDA’s addition of a Chinese API manufacturer to an import alert early last month, the World Health Organization was left without a prequalified source for the birth control drug levonorgestrel, also known as Plan B. Read More
Australia’s Therapeutic Goods Administration is abandoning its goal of 15-day timelines to process GMP clearance filings from overseas manufacturers. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency laid out its top 10 priorities for 2017 and 2018 — including developing a model for the agency’s future, post-Brexit. Read More