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March 02, 2023
Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.
February 27, 2023
The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.
February 23, 2023
Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.
February 15, 2023
Probe targets agency’s role in advising on drug testing and submissions.
February 14, 2023
Sanjay Shukla, MD, MS, CEO of aTyr Pharma, discusses the company's clinical operations and ongoing Phase III study for pulmonary sarcoidosis.
February 13, 2023
EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.
With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.
February 03, 2023
Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.
Craig Coleman, PharmD, Professor at the University of Connecticut, and the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) study's principal investigator discusses the ins and outs of the study.
DCTs and RWD among topics for industry to focus on moving into 2023.