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
Reports of a recall of apple cinnamon fruit pouches for children have been prominent in the headlines for the last few weeks. This blog has previously covered the topics of lead in spices and the FDA’s January 2023 issuance...more
The U.S. Food and Drug Administration (FDA) has issued two new draft guidance documents on pediatric drug development and exclusivity, most notably clarifying that, under a new proposed policy that would come into play upon...more
Baby formula has sadly made headlines in recent years as a result of shortages, plant closures, contamination, and lawsuits. A major infant formula class action lawsuit is ongoing against manufacturers Enfamil and Similac for...more
On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more
Lead poisoning in children has been a known risk for more than 100 years. Toxic exposures to lead and other heavy metals can lead to problems with learning, cognition and behavior....more
What formula brands are affected? This recall only relates to the following Similac®, Alimentum®, and EleCare® powdered formula produce at the Abbott Nutrition plant in Sturgis, Michigan...more
CSPI to FDA: Move to the Front! Watchdog barks at industry efforts to highlight nutrition facts - Gesundheit FOPNL. It’s sweeping the globe. What is it, you ask? A new government agency? An awful skin condition? A...more
The U.S. Food and Drug Administration (FDA) recently held a public meeting as a part of its Closer to Zero: Action Plan for Baby Foods initiative. This plan identifies steps the agency will take over the next three years...more
On March 4, 2021, we posted “Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers.” Multiple plaintiffs had filed class action lawsuits in jurisdictions around the country alleging that baby food...more
The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more
The U.S. Food and Drug Administration recently announced a new initiative called Closer to Zero, which is an action plan that identifies steps the agency will take over the next three years (and beyond) to reduce exposure to...more
On March 5, 2021, FDA issued a public statement announcing regulatory actions to reduce toxic elements — with a particular focus on arsenic, lead, cadmium and mercury — in food for babies and young children. FDA cited the...more
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...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
Product Recalls to Protect the Consumer? Is the Consumer Product Safety Commission, a federal agency charged with protecting the safety of Americans from dangerous and deadly items in the marketplace, doing its job? A...more
As Millions More Vape, Health Effects Clouded in Uncertainty - We thought we had smoking on the run. From 2005 to 2018, the number of Americans that smoke dropped from 21 percent to 14 percent. Then along came...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
In the Wake of Monsanto, All Eyes are on the Cheerios Glyphosate Case - Doss v. General Mills, No. 18-cv-61924 (S.D. Fla Aug.17, 2018) - The Skinny: Last fall, a jury in California awarded $289 million to a plaintiff...more
LEGISLATION, REGULATIONS & STANDARDS - “Shame on you, Washington Post”: FSIS Criticizes Reporting on Pork Inspections - The U.S. Food and Drug Administration’s Food Safety and Inspection Service (FSIS) has issued a...more
On March 5, the U.S. Food and Drug Administration (FDA) simultaneously published its independent testing results confirming the presence of asbestos in certain cosmetic products sold by Claire’s and by the girls'...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Webinar on Genome Editing in Animals - The U.S. Food and Drug Administration has announced an April 25, 2019, public webinar about “genome editing in animals, an...more
Draft Guidance on Food Recalls Issued - The U.S. Food and Drug Administration (FDA) has issued draft guidance on the release of retailer information during the food-recall process. The guidance indicates when the agency...more
Small particles of glass are to blame for the recall of a widely used fluticasone nasal spray that treats symptoms of hay fever in children. The nasal spray, known by its brand name Fluticasone Propionate Nasal Spray USP...more
Senate Committee Proposes Cosmetics Regulation Amendment - The Senate Committee on Health has released a discussion draft of a proposed amendment to the Federal Food, Drug and Cosmetic Act (FDCA) that would establish greater...more
The Northern District of California recently denied class certification to a plaintiff who alleged that Gerber Products misbranded nutritional claims about baby food products in violation of state and federal labeling laws....more