Regulatory Affairs

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

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

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