Regulatory Affairs

FDA to Replace Guidance on Developing New Pain Drugs

FDA Commissioner Scott Gottlieb said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. “Everything is on the table,” Gottlieb said in announcing the move aimed at driving innovation for fresh options to the potent, addictive pain meds. He noted the initiative will include at least four new guidances. Read More

FDA Issues Final Guidance on PBPK Analyses

The FDA released final guidance for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More