Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Sober up, folks! Here we go. With the legalization of marijuana and cannabis products in so many states, dealing with substance abuse in the workplace has become ridiculously complicated. This is the first of a two-part...more
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
The legal landscape relating to the permissible use of medical marijuana in the United States is evolving rapidly, presenting employers with a complex legal environment to navigate, with states taking varying stances on the...more
On May 21, 2024, the Drug Enforcement Agency (DEA) issued a notice of proposed rulemaking indicating that the U.S Food and Drug Administration (FDA) intends to transfer marijuana from Schedule I to Schedule III of the...more
Key Takeaways - As of July 1, Maryland’s Cannabis Reform Act allows adults 21 years of age and older to legally possess up to 1.5 ounces of cannabis flower. However, the state remains without detailed legislation and/or...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
1. Cannabis Entering the Metaverse - As we discuss in greater detail here, the Metaverse provides expansive marketing and sales opportunities for cannabis companies due to its decentralized nature and the varied regulatory...more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....more
In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more
Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration ("FDA") has broadened its net to target businesses making claims that their products...more
With the ever-increasing acceptance of marijuana as a legitimate treatment for a number of medical conditions, a newfound interest in the use of psychedelics as a form of medical treatment is gaining traction once again. ...more
Since California first legalized medical marijuana in 1996, approximately thirty-two other states and the District of Columbia have followed its lead and approved marijuana use for medical purposes. Introduction [1] - ...more
The latest clinical data casts doubt on the safety and efficacy of these antimalarial drugs for treatment of COVID-19, and both the FDA and an Expert Panel of the NIH have just warned against their use outside of clinical...more
Lately, products containing CBD (from beer to skin cream to oils that can be diffused and vaped) seem to be all the rage. Why are CBD products suddenly turning up everywhere (your local Sheetz convenience store for...more
The use of CBD (Cannabidiol) products has become very popular throughout the country. In addition, the laws relating to use of hemp plant products are rapidly evolving. As a result, the United States Department of...more
USDOT safety-sensitive employees cannot use cannabidiol ("CBD") products without impunity. On February 18, 2020, the U.S. Department of Transportation’s Office of Drug and Alcohol Policy and Compliance (“USDOT”) issued a...more
The U.S. Department of Transportation Office of Drug and Alcohol Policy Compliance published a notice on February 18, 2020 concerning the use of hemp and cannabidiol (CBD) products by safety-sensitive employees regulated by...more
When Big Pharma insists its sky-high prices are justified, patients may want to keep in mind key findings just revealed about prescription drugs and their makers...more
Out of a sample of 29 non-representative drug manufacturers surveyed earlier this year, 23 had publicly posted policies related to accessing their investigational drugs outside of the context of formal clinical trials,...more
On June 4, 2018, the Food and Drug Administration (FDA) announced a major restructuring in its Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER). OND currently includes six offices with 19...more
Legalized cannabis is quickly making an entrance into all corners of the United States. Currently, nine states and the District of Columbia have legalized marijuana for recreational use. An additional 20 states allow medical...more
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA’s view, have used “certain ‘gaming’ tactics to delay generic competition.” The list is intended to...more
The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more