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The FDA is seeking feedback on its 2014 compounder registration guidance in the wake of calls for clarification of the differences between traditional and outsourcing compounders. Read More
Two FDA advisory committees have voted to allow an indwelling central venous access device in clinical trials after hearing please from parents of subjects as well as clinical investigators and sponsors. Read More
The FDA could significantly improve clinical trial design and boost investment in Alzheimer’s research and treatment, if it required applicants to meet one endpoint in clinical trials of drugs for Alzheimer’s disease, according to an Alzheimer’s research advocacy group. 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 (OGCP). Every day, OGCP fields questions from investigators, sponsors, IRBs and other interested parties. Here are FDA’s answers to a couple of those questions. Read More
Cutting the costs of clinical trials, developing tools to improve clinical trial enrollment and filling gaps in antibacterial drug development were named as major priorities in the FDA’s fiscal 2018 budget proposal. Read More