Risk-Based Quality and Safety Management in Clinical Trials with Combination Products in Global Regulatory Environment.
Year: 2020
Type: other
Abstract: Background: Newly emerging products which combine drugs, devices, and biologics are expected to provide new opportuni- ties in bridging device and drug capabilities and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4238220536