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
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
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
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more
Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
You've likely seen the headlines. Online recruiting tools that unfairly screen out women and minorities. Facial recognition tools used in law enforcement that misidentify specific demographic groups. Algorithms that place...more
Pharmaceutical companies only need patents for compositions of matter and general methods of use, right? Wrong. Discoveries can happen well into Phase III and IV and pharmaceutical companies should seek patent protection for...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
Life sciences companies were popular targets of class action securities lawsuits in 2018. In the most recent edition of our annual survey, Dechert litigators David H. Kistenbroker, Joni S. Jacobsen and Angela M. Liu examine...more
The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more
On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more