New FDA Guidance Addresses Challenges with Cell and Gene Manufacturing Comparability and Complexity Journal Article 6th November 2023
Webinar Indiana Chapter Virtual Event: Navigating the Regulatory Complexities of AI and Cybersecurity for Medical Devices and IVDs. 1st November 2023
Webinar IRIS Portal – Scientific Advice, Orphan Designation, and i-SPOC application submissions to EMA 3rd November 2022
Webinar What you need to know to submit Study Data to FDA & what the new FDA Technical Rejection Criteria means for you
