The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
A Less is More Strategy for Data Risk Mitigation
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Key Discovery Points: Even AI Experts Can Get Faked Out
PilieroMazza Annual Review: What DOJ’s 2024 FCA Report Means for Government Contractors
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 223: Cybersecurity and Privacy Risks with Healthcare Vendors with Brandon Robinson of Maynard Nexsen
Government Contracts and New Mandates Executive Orders and Cost Recovery Strategies Explained
Podcast: Are Legal Holds Protected by Privilege? Insights from the FTC's Battle with Amazon
Consumer Finance Monitor Podcast Episode: Regulating Bank Reputation Risk
4 Key Takeaways | AI in Precision Agriculture Legal Risks and Mitigation
The Duty to Cooperate Under a Liability Policy
On-Demand Webinar: Bring Predictability and Reduce the Spiraling Cost of Cyber Incident Response
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Everyone Come to Play: Exploring FOCI Mitigation Instruments
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 211: Cybersecurity and Privacy Risks for the Healthcare Industry with Brandon Robinson of Maynard Nexsen
Fraud Prevention Techniques for Nonprofit Organizations - Part 3
Steps Your Nonprofit Can Take to Mitigate Fraud Risks - Part 2
Why Retailers and Merchants Should Pay Attention to the CFPB - The Consumer Finance Podcast
The Justice Insiders Podcast - The Ever-Expanding Net: Corporate Compliance in an Era of Increasing Trade Sanctions and Restrictions
Fraud Risks at Nonprofit Organizations - Part 1
Clinical trial agreements (CTAs) form the foundation of any clinical research initiative, establishing the legal and operational framework essential for a study's success. Crafting, reviewing, and negotiating CTAs require...more
On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
Dangerous products are far more common than they should be. Despite manufacturers’ and retailers’ obligations to avoid putting dangerous products on the market, numerous people suffer serious and fatal injuries caused by...more
Our current food system is facing a myriad of critical challenges. The United Nations predicts that the world population will reach 9.3 billion people by 2050, which means that we will need to produce 60% more food to feed...more
Conducting a recall is a time-sensitive process that requires an informed, strategic, and measured approach. When conducting recalls, companies must take the necessary steps to protect patients or consumers and comply with...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
Our Food & Beverage Team reports good news for the industry: product labels can follow either the Food and Drug Administration’s current version or any new version of a rule defining “healthy.”...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more
When it comes to mitigating the risk of class action lawsuits, the best offense is a good defense. Companies can take many steps to reduce their exposure to class action litigation before it happens, including the tactics...more
The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more
ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more
Key Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...more
FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more
In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success...more
Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more
The COVID-19 pandemic has accelerated the globalization of the life sciences industry, driving cross-border collaborations to develop urgently needed treatments, scale up manufacturing and distribution, and fill raw material...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...more
The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...more
Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more
From the 1978 52nd Street album, Billy Joel sings, “Honesty is such a lonely word, everyone is so untrue; honesty is hardly ever heard, and mostly what I need from you.” While we don’t want to start out this Bulletin on such...more
I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more
Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more
For healthcare and life sciences companies, regulatory disputes with the U.S. Department of Health and Human Services (HHS) and its operating divisions can present significant economic costs and reputational risks. Efficient...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