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The FDA plans to make tools available to provide incentives for doctors or physician groups to collaborate on stem-cell and regenerative medicine products, eventually leading to a biologics license for each doctor or group, CBER Director Peter Marks and Commissioner Scott Gottlieb said in a New England Journal of Medicine article published Thursday. Read More
The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks, a full month longer than the average 10 years ago, according to new research from the Tufts Center for the Study of Drug Development. Read More
As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who shared data integrity compliance tips in an FDAnews webinar Wednesday. Read More
Investigations and lawsuits against opioid manufacturers and distributors continued as Sen. Claire McCaskill (D-Mo.) accused a drugmaker of blocking a Senate investigation and the city of Chicago sued three distributors. Read More
FDA Commissioner Scott Gottlieb called the drug contracting system “rigged” in remarks Wednesday at the America’s Health Insurance Plans National Health Policy Conference in Washington, D.C. Read More
Oxycodone, hydrocodone, fentanyl and morphine products accounted for less than 25 percent of opioids sold between 1992 and 1995, but reached an 80 percent share by 2011. Read More