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
Supply chain disruptions have become a significant challenge for the U.S. FDA-regulated products industry, affecting the availability of pharmaceuticals, medical devices, and food. These disruptions are caused by various...more
Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more
In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...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
Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products...more
On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced that it intends to expand its use of unannounced inspections at foreign manufacturing facilities. This announcement applies to facilities that produce...more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more
In recent years, states have been exploring innovative avenues to address rising healthcare costs and ensure access to affordable medication for their residents. One idea gaining traction involves pursuing authorization from...more
At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
On September 25, 2020, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)....more
On October 15, 2020, the Food and Drug Administration announced that it had reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) manufactured in China that are not approved by the...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
Importing dietary supplements and dietary supplement components can present many challenges. Not the least of which are those required to stay in compliance with aspects of the Food Safety and Modernization Act (FSMA)....more
Life sciences and medical device companies are dealing with an unprecedented crisis. The industry is not only managing the impact of Coronavirus (COVID-19), they are also a solution provider. Companies are rapidly adapting...more
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus (COVID-19) outbreaks in foreign...more
The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans. As a result...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
• FDA issues a Proposed Rule to allow states and other entities to import certain prescription drugs from Canada. • In addition, FDA issues draft guidance for industry to explain how drug manufacturers can import their own...more
Yesterday we started off our year-end series of blog posts with the first part of a review of FDA’s actions for 2017 in the therapeutic products space. Part 1 recapped Commissioner Gottlieb’s initiative to tackle drug...more