Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
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
The medications we take are supposed to protect our health and help us recover from serious illnesses and injuries. Unfortunately, this doesn’t always happen. Some medications cause more harm than good. Dangerous and...more
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more
On January 3, 2025, outgoing US Surgeon General Dr. Vivek Murthy released a new advisory outlining the alleged causal link between alcohol consumption and cancer, claiming “numerous high-quality observational studies and...more
On January 15, 2025, the Food and Drug Administration (FDA) amended its color additive regulations by revoking its authorization for use in food and ingested medications of FD&C Red No. 3 (Red No. 3), a synthetic red dye....more
On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more
The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more
On January 3, the US Surgeon General issued an advisory on the association between alcohol and the risk of cancer. The alcohol beverage industry has swiftly responded highlighting conflicting studies and federal guidelines....more
On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC...more
What Are ADCs and Why Are They Growing? 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...more
Antibody Drug Conjugates (ADCs) are a class of small molecule drugs (also known as a payload) and an antibody conjugated together by a chemical linker. ADCs are designed to target specific cells, such as cancer cells, while...more
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