These guidance documents should provide greater reassurance to digital product developers about how and when FDA will classify and regulate their products.
What can you do during your study to maximize your chances of success when it comes time to submit?
An overview of the PMDA innovative, fast-track regulatory initiatives including the sakigake Designation System and the most recent Conditional Early Approval System.
Questions and concerns as the FDA prepares to develop and implement a program evaluating the potential use of Real World Evidence (RWE) for regulatory decisions.
What is the government doing to improve the affordability, accessibility, and appropriate use of prescription drugs.
Successful regulatory approval requires a deep understanding of the regulations, process and technical standards, as well as an appropriate regulatory strategy.
This webinar provides an overview of the safety reporting requirements of the final rule and assess the areas that are likely to present the greatest compliance challenges.
A video overview of the valuable content that can be accessed as a DIA NOW user.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
How technology-based imaging improves quality and regulatory compliance, and how these improvements benefit sponsors.
In this webinar, INC Research/inVentiv Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
See how a life sciences organization uses CoSign to securely and compliantly sign an FDA form.
DIA’s Conference on clinical trial endpoints will bring together key stakeholders to address critical questions and generate potential solutions to challenges associated with determining study endpoints and outcomes.
The Combination Products Conference will examine the recent and ongoing changes in the regulatory ecosystem for combination product development and approval.
Contracting an in-country clinical depot helps bring costs and timelines under control.