Gardner Law

An FDA law firm specializing in regulatory, compliance, privacy, and litigation matters.

[Law Practice News @Law_Practice]

What's on File Could Be on Trial - Mastering Documentation Risk https://t.co/43LShqp9Mq | by @GardnerPllc

[Gardner Law @GardnerPllc]

What's on File Could Be on Trial - https://t.co/tdfeZhEELX

Every document created in the workplace can carry legal weight. Careless communications—especially those involving humor, sarcasm, or speculation—can become powerful weapons for opposing counsel.

[Gardner Law @GardnerPllc]

The DOJ Criminal Division recently released an updated version of its Evaluation of Corporate Compliance Programs document.

The update presents both challenges and opportunities for companies regulated by the FDA. Read our recent alert!

https://t.co/IzL2zkTjq9

[Gardner Law @GardnerPllc]

Gardner Law Expands Services with Litigation Focus:

We're thrilled to announce the launch of our new litigation practice. Led by industry veteran David Graham. Learn more about our expanded capabilities: https://t.co/QpRZMw6Vhh. #litigation #medicaldevice #food #drug

[Gardner Law @GardnerPllc]

It is essential for manufacturers to ensure that ads are compliant in all respects—including accurately reflecting a product's effectiveness or capabilities.

Learn more about the circumstances of the FDA's most recent untitled letter here:

https://t.co/bWRRqLsHFd

[Gardner Law @GardnerPllc]

A recent U.S. DOJ settlement highlights the importance of having (and following) a policy that prohibits conflicts of interest.

Read this alert to learn strategies for mitigating risks related to conflicts of interest and more.

https://t.co/6v4ZsRDHMN

[Gardner Law @GardnerPllc]

This is your last opportunity to attend to "Due Diligence Decoded: M&A Success in FDA-Regulated Industries"! Gardner Law is hosting this half-day CLE event on Friday, 9/20, from 10:00am - 1:00pm ET at Loft on Two in Boston, MA and virtually. Register: https://t.co/5kENt1WL20

[Gardner Law @GardnerPllc]

This summer, Paul Rothermel presented a three-part webinar series “Privacy Summer School” covering key privacy topics. These programs covered key areas of compliance and risk. Check out our alert for a series recap and links to the session recordings. https://t.co/jZF8tupEx3

[Gardner Law @GardnerPllc]

Next week, Gardner Law is hosting "Due Diligence Decoded: M&A Success in FDA-Regulated Industries", a half-day CLE event on Friday, September 20, 2024, from 10:00am - 1:00pm ET. Attend virtually or in person at Loft on Two in Boston, MA: https://t.co/8pjvkFKglO

[Gardner Law @GardnerPllc]

The Biosecure Act has garnered significant bipartisan support and is increasingly poised to become law, heightening its impact on the life sciences industry.

Read our recent alert for recommendations for biotech and pharmaceutical companies. https://t.co/H5nJKooIuV

[Gardner Law @GardnerPllc]

The DOJ has unveiled a new three-year pilot program designed to incentivize individuals or "whistleblowers" to report corporate misconduct. Read more for details about the program and the potential impact on both corporations and individuals. https://t.co/qedtGp5gcK

[Gardner Law @GardnerPllc]

While securing approval from the FDA is a major milestone in the process of bringing a new drug to market, this is not the end of the road when it comes to federal compliance. Read our alert to discover the risks involved after approval: https://t.co/Di2jUx2FyT

[Gardner Law @GardnerPllc]

The HHS OIG recently announced a $12 million settlement with medical device manufacturer Innovasis Inc. following an investigation into alleged kickback practices. Read the alert to discover the top lessons learned from the settlement. https://t.co/22ErLn558x

[Gardner Law @GardnerPllc]

In a recent article, Senior Attorney Nathan Downing shared his thoughts on the risks pharmaceutical manufacturers face when using social media influencers to promote their drugs—and what the FDA can, and should, do to provide sufficient guidance. https://t.co/kyy82bz6Nk

[Gardner Law @GardnerPllc]

Join us tomorrow at 1pm CT for the final webinar in our Privacy Summer School series. In "Privacy Policy Pop Quiz – Are You Ready?", learn about the latest privacy policy requirements in this overview of website privacy compliance. Register now: https://t.co/NQglKITEZL

[Gardner Law @GardnerPllc]

The FDA released draft guidance on how and when manufacturers and pharmaceutical orgs can respond to misinformation about their products online. Encountering false or misleading statements about your products on online platforms? Read more: https://t.co/Al0tkVNVqu

[Gardner Law @GardnerPllc]

News: Drug and biologic submissions that include Real-World Evidence (RWE) meeting specific criteria will now be aggregated. Understand the new reporting criteria and what it means for your company's use of real-world data here: https://t.co/4HNkDQAPIL

[Gardner Law @GardnerPllc]

The FDA’s Center for Devices and Radiological (CDRH) recently announced a partnership with the Bill & Melinda Gates Foundation. Learn more about the benefits of this partnership and its potential impact on the FDA-regulated industry. https://t.co/dKaM9RUdfF

[Gardner Law @GardnerPllc]

You're invited to a half-day CLE event on Sept. 20th from 9am - 12pm ET at Lofts on Two in Boston, MA and virtually. Whether you're a buyer or seller, this session is invaluable for anyone involved in FDA-regulated transactions. Register now here: https://t.co/8pjvkFKObm

[Gardner Law @GardnerPllc]

This Thursday, we'll discuss the dos and don’ts of providing information to the government, how to protect your company and its employees, and ways to minimize the burden on your company in our Government Investigations webinar series.

Register now: https://t.co/qDE0tkHapj