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
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of...more
On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding a series of questions and...more
Earlier this month the FDA issued guidance listing general factors for study sponsors to take into consideration to assure the safety of clinical trial participants, maintain a good clinical practice, and minimize risks to...more
The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more