Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
Don’t miss our annual conference devoted to higher education and research compliance - Attend the Higher Education & Healthcare Research Compliance Conference June 10–12, 2024 and hear from experienced professionals on a...more
In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more
New federal requirements for posting of clinical trials information address how data collected in clinical trials are submitted for public consumption. The requirements were revealed on Sept. 16 when the Department of Health...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
The US Food and Drug Administration (FDA or the Agency) issued draft guidance on June 18 about assessing the benefits and risks for Investigational Device Exemption (IDE) applications. The draft guidance provides a...more
On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more
The FDA recently released three warning letters that it previously issued to two health care providers relating to prescription drug and medical device clinical trials. The letters, sent in late 2013 and early 2014, detail...more
In its proposed update to the Physician Fee Schedule for calendar year 2014, the Centers for Medicare & Medicaid Services (CMS) suggested major revisions to its regulations governing Medicare coverage of investigational...more
On February 25, 2013, the U.S. Food and Drug Administration (FDA) released a proposed rule entitled Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices. The proposed rule would require that...more