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
On March 11, 2020, World Health Organization Director-General Tedros Adhanom declared that the COVID-19 outbreak "can be characterized as a pandemic," and cautioned that the WHO has "rung the alarm bell loud and clear." At...more
In his first week in office, President Donald Trump issued executive orders and took other actions with significant implications for the life sciences and health care industries that mark substantial departures from the...more
AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more
Life sciences industry has regulatory compliance at the center of all its operations, so maintaining the integrity of data has always been a pressing need for this industry globally. Regulators such as the United States Food...more
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more
During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more
In Washington: Sens. Ben Cardin (R-MD) and Marco Rubio (R-FL) led a letter from a group of 31 senators calling on Senate leadership to include an international response to COVID-19 in the next coronavirus package....more
In Washington: Sen. Debbie Stabenow (D-MI) and Senate Minority Leader Chuck Schumer (D-NY) will be launching a messaging campaign on “the cost of Republican inaction during the COVID-19 crisis.” Schumer said President...more
On May 4, 2020, the Food and Drug Administration (FDA) updated its “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) | Immediately in Effect Guidance for Clinical Laboratories, Commercial...more
Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more
We have previously reported on the complicated naming issues surrounding biosimilar products and how biological qualifiers, such as three or four-letter codes, should be added to distinguish between them. However, the...more
On June 2, 2016, the FDA filed a notice for comments on guidance requesting that biologic applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name...more
On May 31, 2016, the FDA issued a notice that FDA’s Center for Biologics Evaluation and Research (FDA/CBER) intends to “enhance technical collaboration and cooperation between the FDA, WHO, and its member states to facilitate...more
On January 26, 2016, the World Health Organization (WHO) unveiled the final version of its proposal for a worldwide biosimilar naming convention. The WHO proposes to add a “biologic qualifier” (BQ), which consists of four...more
The Federal Trade Commission (FTC) last week disputed the effectiveness and competitive impact of the Food and Drug Administration’s recently proposed biosimilar naming policy and argued that using different nonproprietary...more
On August 27, 2015, the U.S. Food and Drug Administration (FDA) released long-awaited and highly anticipated draft guidance regarding the non-proprietary naming of biological products, including biosimilars. The draft...more