Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
One of the fastest ways to garner unwanted attention as a publicly-traded life sciences company is to be accused by either a regulator or stockholder that the company disclosed materially misleading information about the...more
Digital health and other life sciences/tech developers, particularly those producing innovative new solutions, offer dynamic opportunities for investors, in part due to the continued evolution of the US Food and Drug...more