A Third Party's Perspective on Third Party Risk
The EU Corporate Sustainability Due Diligence Directive
Regulatory Phishing Podcast - The Impact of Cybersecurity Compliance on Corporate Transactions
5 Key Takeaways | Risks Facing Banks Today
Anonymization and AI: Critical Technologies for Moving eDiscovery Data Across Borders
Commercial Financing Regulatory Developments - The Consumer Finance Podcast
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Paralegal Insights: A Collaborative Trademark Practice
The S in ESG - What is it and how can it create value?
Hidden Traffic Podcast - More About the Uyghur Forced Labor Prevention Act with Virginia Newman
FCA Implications for M&A Transactions
PFAS: Increasing Regulations and Managing Legal Liability
[Webinar] Cannabis Real Estate 101: A Primer for Social Equity Applicants & Entrepreneurs
Quality Of Earnings: Making The Most Of M&A Transactions
FCPA Compliance Report - Karen Woody on JPMorgan and Nikola SEC Enforcement Actions
Kasey Ingram and Rocco Debitetto on Bankruptcy and Compliance
FCPA Compliance Report - John Katsos - Due Diligence in Conflict Zones
Krista Muszak and Louis Perold on M&A Due Diligence in Emerging Markets
FCPA Compliance Report - Brandon Daniels - Ongoing v. Point in Time Due Diligence
German Supply Chain Due Diligence Act and Its Impact on Latin America
Katie Steiner on Compliance & Corporate Art Collections
Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...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
Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more
When conducting due diligence of an FDA-regulated company, there are several important questions that should be posed. These include questions relating to regulatory, compliance, and privacy matters. For example, questions...more
Bidding for attractive businesses in the pharma services space continues to accelerate, with new interest emerging daily from investors who traditionally have not focused on the sector. With this influx comes an urgent need...more
While the ability to market medical products is bound by the claims that can be lawfully made, it does not mean the claims available at acquisition are all your company will have. Consider developing a plan to create...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
After a year-over-year reduction in drug, device, and biologic Warning Letters from 2012 through 2019, Warning Letters spiked to pre-2014 levels in 2020 during the pandemic. This was due in large part to a significant number...more
Join Gardner Law and colleagues live from Lord Fletcher's on Lake Minnetonka, Minnesota for a complimentary CLE event. Hear from a panel of experts on compliance, data breaches, FDA regulations, privacy, and more....more
Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more
As the European Union (“EU”) continues to debate whether downstream responsibilities will fall within the contours of its hefty Corporate Sustainability Mandatory Due Diligence Directive (“CSMDD”), and the EU Council just...more
The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....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
AGG is pleased to present the second episode in a podcast series titled, “I Wish I Know What I Know Now: Conversations with AGG on FDA Issues,” covering key due diligence issues to consider when acquiring or investing in life...more
The cannabis industry is growing in leaps and bounds, but entrepreneurs interested in developing cannabis companies – as well as business people interested in investing in them – must make certain that they know what they are...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
In the first case following Akorn v. Fresenius to rule on a party’s entitlement to terminate a merger agreement on the basis of a material adverse effect (MAE), the Delaware Court of Chancery ordered Boston Scientific...more
USPTO Issues CBD Trademark Guidelines in Light of the 2018 Farm Bill: Key Takeaways - On May 2, 2019, the USPTO released its new guidelines on how it will examine federal trademark applications for CBD products in light of...more
The recent decision of the Delaware Court of Chancery in Akorn, Inc. v. Fresenius Kabi AG et. al is the first time a Delaware court has found a material adverse effect in the M&A context, and reinforces current Delaware law...more
This is the fourth article in our five-part series on PTE. When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more
On March 1, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) published a final guidance entitled, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators”...more