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
On August 1, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Mirati Therapeutics Inc., a Bristol Myers Squibb Co. (Mirati), relating to promotional...more
Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...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
Antibody-drug conjugates (ADCs) are a promising class of cancer treatments with an accelerating number of U.S. Food and Drug Administration (FDA) approvals and rapidly growing market size, as discussed in previous articles in...more
Over the past few years economic headwinds have resulted in fewer deals, with companies and private equity firms alike reassessing where to spend money. But one portion of the pharmaceutical industry is bucking this trend in...more
HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more
The perils of searching for beauty and longevity - We all want to look attractive: to family, friends, and lovers. But there is such a thing as trying too hard to buff up our appearance, and in this Valentine’s month,...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...more
On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other...more
On July 14, 2023, the World Health Organization (WHO) published a summary of two findings regarding aspartame, an artificial sweetener found in many consumer products. One finding categorized aspartame as “possibly...more
On June 29, the World Health Organization (WHO) announced that the widely used artificial sweetener, aspartame, is set to be declared as “possibly carcinogenic to humans” by the International Agency for Research on Cancer...more
LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more
In a growing trend to regulate the chemicals contained in consumer products, numerous states are enacting laws and regulations to address the presence of 1,4-dioxane in consumer products. 1,4-dioxane is a synthetic industrial...more
On August 25, 2022, the Supreme Court of New Jersey issued its decision in Rivera v. The Valley Hospital, Inc., reversing the trial judge’s interlocutory order denying the defendants’ motions to dismiss a claim for punitive...more
Report on Research Compliance 19, no. 4 (April, 2022) - A six-year review of the institutional review board (IRB) at National Jewish Health (NJH) of Denver has been resolved, with the organization outsourcing the...more
What is the latest with the CPAP lawsuits? As 2022 begins, the thoughts of sleep apnea patients and their families are, naturally, returning to the Philips CPAP machine recall 2021....more
Alpha Tau Medical Ltd. (“Alpha Tau”) is a medical technology start-up focused on the research, development, and commercialization of its Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) treatment for solid cancerous...more
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more
On Feb. 5, 2021, the Food and Drug Administration (FDA) granted approval for a new CAR T-cell therapy, Breyanzi® (lisocabtagene maraleucel), to Juno Therapeutics, a subsidiary of Bristol-Myers Squibb (BMS). Breyanzi® is...more
Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more
Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more
A U.S. Food & Drug Administration (FDA)-prompted Class 1 recall one year ago led an Ireland-based company to stop manufacturing and marketing its cancer-causing, textured breast implants and tissue expanders. The recall, the...more