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October 2017

Vol. 22
No. 10


FDA Commits to Patient Engagement at Inaugural Advisory Committee Meeting

Examining how well medical device companies engage with patients in clinical trials is becoming part of the new normal at the FDA, say agency officials. Read More

Changes Needed for EDC to Show True Efficiency

Three quarters of clinical trial managers still report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases, according to new research from the Tufts Center for the Study of Drug Development and Veeva Systems. Read More

FDA Signals Greater Use of Real-World Evidence

The FDA is committed to using real-world evidence in drug approvals and post-market evaluations, and forthcoming guidance will describe RWE and its potential for satisfying FDA’s pre- and post-market requirements. Read More

FDA Calls for More Clinical Studies for Rexista

The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional clinical studies of the drug’s abuse-deterrent properties. Read More

Toxicity in Clinical Trials Trips Renal Cell Carcinoma Drugs

An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. FDA representatives noted the drug was associated with more toxicities than the placebo in clinical trials. Read More

Dr. Angela J. Bowen Remembered As IRB Pioneer

Angela J. Bowen, a medical research pioneer, philanthropist and founder of Western Institutional Review Board, which grew to become the world’s largest independent review board, died at her home in Olympia, Washington on Aug. 31. Read More

FDA Wants to Plug in Sooner to Drug Development, Gottlieb Says

The FDA is looking to improve the design of clinical trials and it plans to get involved with sponsors earlier in the development process for new drugs, and to help speed the drugs to market, Commissioner Scott Gottlieb said. Read More

Advisory Committee Finds Insufficient Data for Duchenne’s Drug’s Efficacy

An FDA advisory committee voted 10 to 1 that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective, noting problems with interpreting data from clinical trials. Read More

EMA to Update ICH Guidelines on Clinical Trial Statistics

The European Medicines Agency is considering a draft addendum developed by the International Conference on Harmonization for the ICH’s 1998 clinical trial statistics guideline. Read More

OMB Mulls One-Year Delay of Common Rule Revision

The White House’s Office of Management and Budget (OMB) proposes to delay for one year, until January 2019, the effective date of a revision to the sweeping Common Rule that governs federal policy on the use of human subjects in clinical trials. Read More