US FDA To Sponsors: Tell Us More About Your Drug Development Before We Meet
Executive Summary
Requests for meetings with FDA staff about products in development should include pertinent details about pediatric study plans, human factors engineering plans and combination product information; new guidance documents on formal meetings under PDUFA VI and communications with IND sponsors operationalize user fee program commitments and will promote earlier, more thorough engagement, agency says.
You may also be interested in...
US FDA's Gottlieb Touts 'Seamless' Clinical Trials, Worries About Second-To-Market Products
Commissioner tells House hearing that agency study found troubling drop in innovative competition; clinical trial reform, including encouraging surrogate markers, could speed development of products that may create pricing pressure on brands.
Patient Experience Data: Industry Seeks US FDA Clarity On Submission Pathway And Labeling
Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.
FDA Reviewers Share CMC, GMP Challenges In Last Year's Rush To Approve New Therapies
Inundated with high-priority applications last year, US FDA's CMC reviewers struggled with seemingly thrown-together review packages, moving-target manufacturing processes and not-on-the-same-page contract manufacturers.