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 Wednesday, June 10, 2020, Governor Janet Mills issued a proclamation extending Maine’s state of civil emergency through July 10, 2020. This is the third proclamation renewing the state of civil emergency....more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. In today’s report...more
The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more
On 19 March 2020, the Ministry of Health, Labour and Welfare of Japan (MHLW) issued a notice announcing a waiver of the statutorily-required waiting period after submitting a request for clinical trial to the MHLW in respect...more
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
Cybersecurity and Health Information Privacy During the COVID-19 Pandemic - In following CDC guidelines to effectively navigate the spread of COVID-19, many employers are closing their doors for a period of time and...more
On Wednesday, March 18, 2020, the Food and Drug Administration (“FDA”) issued a guidance document titled, “FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic” (the “Guidance”)....more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
The Belgian Federal Agency for Medicines and Health Products (AFMPS) released a series of guidance and recommendations over the last few days in relation to the COVID-19 outbreak. ...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus....more
As healthcare providers and universities respond to the spread of COVID-19, legal counsel at these institutions should be prepared to assist their institution’s research enterprise in anticipating and reacting to any changes...more