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
California Bans Several FDA-Authorized Food Additives; New York May Soon Follow - On October 7, California Governor Gavin Newson signed into law AB-418, the California Food Safety Act, which completely bans, on safety...more
FDA joins industry groups in opposing Prop 65 cancer listing for BPA - Chemical Watch - The US Food and Drug Administration has joined a pair of industry trade groups in opposing the potential listing of bisphenol A as...more
The California Office of Administrative Law (OAL) recently approved a revised Proposition 65 warning label requirement for the use of acrylamide in food and beverages. California’s Office of Environmental Health Hazard...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
The U.S. Food and Drug Administration (FDA) has issued guidance indicating that it will not enforce particular provisions implementing the Food Safety Modernization Act (FSMA). “In certain situations the FDA has determined it...more
The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the...more
On August 28, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead state agency for the assessment of health risks posed by chemical substances, released a draft report concluding its review of the...more
On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to amend the Proposition 65 regulations. Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986,...more
On July 15, 2020, a California state court made an important ruling upholding the validity and application of regulations exempting coffee from Proposition 65 warnings. Better known as Proposition 65, the California’s...more
Many of us think of coffee as a morning essential, however, there has been a long running debate between California regulators, courts, business, and consumer advocates regarding whether coffee must have a Proposition 65...more
New year, same notices! Prop. 65 filings have not slowed down, and predictably, the same chemicals are being targeted by noticing parties. In my survey of notices filed between December 15, 2019 and the present date, there...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues First Warning Letter for FSMA Foreign Supplier Program - The U.S. Food and Drug Administration (FDA) has issued the first warning letter enforcing the Food Safety...more
FDA Holds Public Meeting on Cannabis - On May 31, 2019, the U.S. Food and Drug Administration (FDA) held a widely anticipated public hearing with stakeholders on cannabis and cannabis-derived compounds to gain insights on...more
Focus - Major automakers back compromise on U.S. vehicle emissions rules, urge deal - Reuters – June 6 - In a letter to California Governor Gavin Newsom, a group of 17 major automakers, including General Motors Co,...more
Millions of Americans, including many grandmothers, suffer from pain, whether it be from swollen joints, bad backs, headaches or stiffness – and dozens of other reasons. For those who do not or cannot take prescription...more
This post summarizes several regulatory developments related to cannabis and cannabis derivatives, including cannabidiol (CBD). The Food and Drug Administration (FDA) recently announced it will hold a public meeting on May...more
LEGISLATION, REGULATIONS & STANDARDS - USDA, FDA Announce Joint Regulation of Cell-Cultured Livestock and Poultry Products - The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have...more
There have been several major developments in the Proposition 65 world this summer. Below we summarize these latest developments in more detail. They include: (1) the California Court of Appeal, First Appellate District...more
As has been widely reported, in May 2018, a Los Angeles Superior Court judge ruled that Prop 65 warning labels are required to be placed on “ready-to-drink” coffee products. Acrylamide, a Prop 65 listed chemical that...more
A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning...more
A recent appellate decision from the Second District Court of Appeal in Los Angeles has determined that breakfast cereals do not require a Proposition 65 warning for acrylamide. Post Foods, LLC v. Superior Court of Los...more
Proposal Would Move Food Regulation to USDA - As part of a proposal to reorganize several federal agencies, the Trump administration has recommended that food-safety regulatory oversight be shifted to the U.S. Department...more
The food and beverage industry has experienced significant change in recent years. New technological developments are enhancing the way food producers track food safety issues, food-labeling remains a hot-button issue, and...more
TSCA/FIFRA/TRI - Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the...more