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The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more
On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) opened a comment period in advance of a proposed rule on labeling requirements for meat and poultry products comprised...more
The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more
On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more
Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more
While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a...more
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more
On May 31, 2019, the Food and Drug Administration (FDA) held its first public hearing concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food,...more
The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more
One of the FDA’s recent biosimilar guidance documents has drawn criticism for eliminating labeling information necessary for physicians to make prescribing decisions. The guidance document, titled, “Scientific Considerations...more