Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
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
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
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
Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
For more than 20 years, the movement to decriminalize and/or legalize cannabis has gained momentum and support across the U.S., resulting in substantial legal reform at the state level that continues today. In recent years, a...more
FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act. Key Points: ..The Food and Drug...more
The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or...more
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more
APA Challenges to DEA Cannabis Policy: "Hot" Hemp and Research-Grade Cannabis - The beginning of spring brought some interesting developments in administrative legal challenges to the U.S. Drug Enforcement Administration...more
Thank you for reading the April 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss two ongoing administrative legal challenges to the U.S. Drug Enforcement Administration's policies on...more
DEA Calls for Increased Production Quotas for Research-Grade Cannabis and Psychedelics in 2022 - While it may come as a surprise to some, the U.S. Drug Enforcement Administration (DEA) has called for significantly...more
The October 2021 issue of Sterne Kessler's MarkIt to Market® newsletter discusses a precedential TTAB decision regarding fraud; the DEA's proposal to increase production quotas for several schedule I controlled substances,...more
Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more
Although many states have legalized marijuana for medicinal and/or recreational use, when it comes to using marijuana in a research setting, sources have been very limited. The US Drug Enforcement Administration (DEA) has...more
The U.S. Food and Drug Administration (FDA) recently released the Draft Guidance for Industry, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. In this guidance, the FDA defers to the...more
Since the start of the ongoing outbreak, the cannabis industry has been the source of some debate as stakeholders and active consumers attempt to understand COVID-19’s far-reaching effects. Pulmonologists and lung experts...more
FDA took two important steps last week to clarify the regulatory landscape for cannabis products, including CBD products. First, FDA issued a draft guidance on Quality Considerations for Clinical Research Involving Cannabis...more
On Tuesday, July 21, 2020, the U.S. Food and Drug Administration (FDA) released a new draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. The draft guidance is intended to...more
Earlier this week, the U.S. Food and Drug Administration (FDA) released draft guidance on the use of cannabis and cannabis-derived compounds in clinical research. This guidance represents an important step towards normalizing...more