The FDA’s November 2021 draft guidance for contents of premarket submission for device software functions may have been a desperately needed update for a legacy 2005 guidance, but stakeholders see one glaring omission from the draft. Both the Advanced Medical Technology Association and Pharmaceutical Research and Manufacturers of America pointed to the absence of sign-off by the FDA’s Center for Drug Evaluation and Research (CDER) for the draft, a conspicuous omission because a combination product with software may include a drug regulated by CDER.
U.S. FDA regulation of combination products has always been complicated, and a new final guidance takes up the long-standing controversy over FDA review of these applications. The final guidance makes explicit the possibility that the individual components of a cross-labeled combination product will be reviewed separately, a concession that industry saw as critical to ensure that these applications can make it through the FDA gauntlet without undue delay.
Cansino Biologics Inc. has entered a development and commercial supply partnership with Aerogen Ltd. for an inhalable version of its COVID-19 vaccine, Convidecia, also known as Ad5-nCoV. Cansino will combine Convidecia with Aerogen’s vibrating mesh aerosol drug delivery technology to produce a consistent droplet size for optimal lung deposition.