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
In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more
In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more
Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or...more
Al Stewart’s 1970s song, “On the Border,” comes to mind every so often when an existing or new client contacts us as their product is stopped at the United States border by the Food and Drug Administration. Lately, during...more
In response to shortages of Personal Protective Equipment (PPE) critical to limiting the spread of and mitigating the impact of COVID-19, the United States has recently issued a series of rules, memoranda, and other guidance...more
Foreign-made drugs, nutritional supplements and medical devices imported into the United States with false or misleading labeling or designed to look like an established competing product in violation of the Lanham Act could...more
ANTICORRUPTION DEVELOPMENTS – Canadian Mining Company Settles with SEC over FCPA Charges – On March 26, Kinross Gold Corporation settled with the Securities and Exchange Commission (SEC) over its alleged failure to...more
Earlier this month, The Washington Post reported that Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that he was reallocating three dozen employees to international mail facilities (IMF), as well as...more
On May 11, 2017, FDA announced a new updated fact sheet and a guidance related to the use of a Unique Facility Identifier that is acceptable under the Foreign Supplier Verification Program ("FSVP") regulation. The three-page...more
The Food and Drug Administration (FDA) issued a final rule on November 29, 2016, establishing requirements for the electronic filing of import entries of FDA-regulated products. Once the rule takes effect, the entries must be...more
In The Eagles’ song, “Hotel California,” Don Henley sings, “You can check out anytime you want, but you can never leave.” Life science companies can try to import all they want, but that doesn’t mean the products will make it...more
Participating agencies jointly target commercial imports that threaten health and safety - U.S. Customs and Border Protection (CBP) announced on April 1 that three additional Federal agencies have formally joined the...more