Scott Gottlieb was sworn in as FDA commissioner May 11 and has his first full day on the job today. Read More

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

The Senate confirmed Scott Gottlieb as the new FDA commissioner May 9 in a 57 to 42 vote. 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

Australia’s Therapeutic Goods Administration is proposing to expand its authority to impose sanctions and penalties for non-compliant ads. 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