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 June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more
When products in your shipment violate—or appear to violate—FDA laws and regulations, the FDA may detain your product and issue a Notice of FDA Action with the designation of “Detained.” This notice is considered the Notice...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
In the past week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS) announced three new initiatives related to food safety and food supply chain transparency....more
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more
Since the fall 2023, the United States has been facing a massive recall of apple cinnamon fruit purees (like apple sauce) due to the presence of elevated levels of lead which caused the product to be considered adulterated...more
On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements. The exemptions followed...more
In November 2022, the U.S. Food and Drug Administration ("FDA") finalized a rule imposing additional recordkeeping requirements for certain foods to "help the Agency rapidly and effectively identify recipients of foods to...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
As the global economy faces the third year of the pandemic, manufacturers are no longer focused on figuring out when things will return to “normal.” Instead, they are applying lessons learned from the past few years to become...more
Report on Supply Chain Compliance 3, no. 10 (May 14, 2020) -... So much of the U.S. shelters in place to help slow the spread of COVID-19, more consumers are using delivery services to get grocery and restaurant...more
FDA first raised the concept of Master Files for dietary supplements in its 2016 revised NDI Guidance. The agency views master files as a tool to promote better compliance with NDI notification requirements. Ingredient...more
Report on Supply Chain Compliance 3, no. 5 (March 5, 2020) - Republican Sen. Josh Hawley of Missouri announced via Twitter that he would introduce legislation to protect the U.S. medical product supply chain following its...more
Report on Supply Chain Compliance 3, no. 5 (March 5, 2020) - The United States Food and Drug Administration warned Jimmy John’s Franchise LLC that the corporation has “engaged in a pattern of receiving and offering for sale...more
Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more
Report on Supply Chain Compliance 2, no. 20 (Oct. 24, 2019) - The United States Federal Trade Commission (FTC) issued a monetary penalty for “greenwashing” last month, the first such penalty imposed on a company for falsely...more
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to verify product identifiers of...more