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
With every major advancement in the field of aging biology, humankind is one step closer to turning back the clock and restoring our youth. In our previous longevity blog, we highlighted several novel therapeutics that have...more
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought. It should not be. Food packaging has become an increasingly hot topic among federal and state regulators,...more
Marijuana is currently classified as a Schedule I drug under the Controlled Substances Act (“CSA”), defined as a substance having “no currently accepted medical use” and “a high potential for abuse.” Other Schedule I...more
In recent years, the global spotlight has illuminated the grave concerns surrounding human rights violations within China's Xinjiang region, particularly those impacting the Uyghur population. The Uyghur Forced Labor...more
By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as...more
On June 30, 2021, the House Committee on Appropriations (the “Committee”) issued a report accompanying a bill making appropriations for the U.S. Department of Agriculture, Food and Drug Administration (“FDA”), and related...more
FDA’s Office of Pharmaceutical Quality (OPQ) issued a new Manual of Policies and Procedures (MAPP) in June explaining the agency’s internal procedures for evaluating color additives and flavors in an oral drug product...more
Approximately ten days after the first federal court decision in the country about mandatory-COVID-19 vaccinations by an employer, Bridges v. Houston Methodist Hospital (the “Hospital”), 153 of the Hospital’s employees were...more
In the first ruling of its kind nationwide, a federal court in Texas has upheld a hospital’s policy requiring employees to be vaccinated against COVID-19 as a condition of continued employment... ...more
In an effort to help bring potentially life-saving COVID-19 treatments more quickly to market, the United States Patent and Trademark Office (USPTO) announced yesterday that it will accept petitions to advance the initial...more
A little more than a week after California’s groundbreaking California Consumer Protection and Privacy Act (CCPA) went into effect on January 1, the Senate Health Committee unanimously approved A.B. 713, introduced by...more
At the end of July 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump Administration’s two-part...more
Water: two parts hydrogen, one part oxygen. It seems simple enough, but for companies selling bottled water, liability lurks below the surface. According to a recent lawsuit, consumers care not only about what is in their...more
The legality of marijuana (also known as cannabis) has been a popular topic in recent years with thirty states and the District of Columbia having laws that legalize marijuana in some form. However, under federal law,...more
The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more