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
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
I. Key Takeaways - - The Secretary of Commerce is investigating the effects of imports of pharmaceuticals and pharmaceutical ingredients (and their derivative products) on national security to support potential tariffs or...more
On March 25, 2024, the Federal Circuit issued an opinion in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., addressing whether the act of importing two heart valve systems for a medical conference was within the...more
The Federal Circuit will consider the relevance of an alleged infringer’s intent in a safe harbor analysis in the appeal of Edwards Lifesciences Corp. v. Meril Life Scis. Pvt.1 The District Court granted summary judgment that...more
A private equity client asked us recently to assess a rumor that FDA was on the warpath in enforcing the 510(k) requirement on medical devices from a particular region. Such a government initiative would significantly deter...more
There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...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
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 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
FDA Released Food Traceability Proposed Rule – The United States Food and Drug Administration (FDA) is proposing to establish additional traceability recordkeeping requirements for manufacturers, processors, packers or...more
In a June 6 Letter of Authorization (LoA), the U.S. Food and Drug Administration (FDA) reissued its March 28 LoA to revise emergency use authorization (EUA) eligibility criteria for imported, non-National Institute for...more
Yesterday, the US Food and Drug Administration (FDA) revised its Emergency Use Authorization relating to disposable respirators made in China that are not approved by the US National Institute for Occupational Safety and...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
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
On April 3, the U.S. Food and Drug Administration (FDA) posted a notice that it has created a special email address in order to assist importers who are experiencing delays bringing COVID-19-related supplies into the...more
In light of the widely reported shortage of personal protective equipment (PPE), ventilators, other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies. President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...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
Under the Trump administration, foreign device manufacturers may see new compliance pressures and increased inspections by the FDA. In this video, Michael Heyl discusses this growing trend and shares insights on how foreign...more
What impact will the U.S. Food and Drug Administration’s significant reorganization efforts have on how the agency regulates medical technology? The agency is reorganizing the Office of Regulatory Affairs (ORA) and combining...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