The RAPS Wisconsin Chapter is hosting a webcast on Wednesday, June 23, 2021, discussing device requirements for drug-led combination products. Hyman, Phelps & McNamara, P.C.’s Adrienne Lenz will be the speaker. This webcast will cover U.S. FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), registration and listing, and post market reporting. Attendees will gain a broad understanding of integrating device requirements into plans for development, NDA submission, and post market compliance. A live Q&A portion with the speaker will follow the presentation.
FDA Law Blog readers are offered a discount of $5 off the RAPS member and nonmember prices. ($5 for RAPS members and $20 for nonmembers). The discount code is: CHAPSPK5315DF. You can access the webcast information and sign up for the event on the RAPS website.