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
When we talk about advertising claims (e.g., on product labels, websites, social, etc.), we stress that "claims must be truthful, not misleading, and substantiated." The requirements to be "truthful and not misleading" seem...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Wellness claims are everywhere. Do they work? Ah, wellness! Such a positive word! Such a noble aspiration for all of us! And such an opportunity for hucksters, hokum and high jinks in the eternal battle to separate...more
Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
“I’m Looking Through You” and “You Won’t See Me,” both songs from The Beatles’ 1965 Rubber Soul album, came to mind when we read the Food and Drug Administration’s recently issued document, “Presenting Quantitative Efficacy...more
ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more
Hosted by American Conference Institute, the FDA Boot Camp returns for its 40th iteration with the continued intent of providing the working knowledge of core essentials of FDA law and regulation, including the new amendments...more
After a long year of chasing big tech and headlines, the FTC needed a break. And what better way to soothe the soul than a nice stretch of the law. Seemingly out of nowhere, the agency just issued a new guidance...more
After two years of decreased enforcement activity (with an out-sized portion of activity being COVID-19-related), the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) has issued several Untitled...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
1. PAAB’s Accelerated Review Options - In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more
A new ban on “Detailed Targeting” options for advertisers on Facebook and other Meta-owned social media platforms – which includes restricting marketing based on “health causes” – takes effect January 19, and may make it more...more
A panel of the National Advertising Review Board (NARB), which hears appeals from the National Advertising Division (NAD) of BBB National Programs, has recommended that Colgate-Palmolive Company discontinue the claim that...more
On January 15, in response to a petition from Acurian seeking clarification on the non-commercial purpose exemption, the FCC held that prerecorded calls to residential phone numbers seeking participants for FDA-mandated...more
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
The digital health market is projected to reach $536.6 billion by 2025 and transform every aspect of healthcare. Which advances hold true potential and which are just hype? Find out at a new Manatt webinar. Digital...more
This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more
Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more
On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more
When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even...more
Late last week, the FTC Business Center Blog posted a short but important entry on health-related advertising representations entitled 5 principles to help keep your health claims healthy. This friendly reminder highlights...more