News & Analysis as of

Life Sciences › FDA Approval › Enforcement Actions

Polsinelli

Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to have Minimal Impact

Polsinelli on

Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....more

American Conference Institute (ACI)

[Event] 42nd FDA Boot Camp - March 13th - 14th, New York, NY

American Conference Institute (ACI) on

ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more

Knobbe Martens

Updates in the FDA’s Regulation of Digital Health Technologies

Knobbe Martens on

The FDA issued a warning letter to Abiomed, for failing to seek approval for its Impella Connect System software before putting it on the market. The Impella Connect System software is designed to work with the company’s...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

Arnall Golden Gregory LLP on

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Knobbe Martens

Affordable Healthcare Solutions Pleads Guilty to Dealing in Non-FDA Approved Devices

Knobbe Martens on

The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...more

Fenwick & West LLP

SEC Fines Life Sciences Company for Regulation FD Violations

Fenwick & West LLP on

For the first time in six years, the U.S. Securities and Exchange Commission issued an enforcement action against a company solely for Regulation FD violations. On Aug. 20, the SEC announced that it charged life sciences...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

Sheppard Mullin Richter & Hampton LLP on

In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Foley & Lardner LLP

Seven Key Questions in Understanding the Current Regulatory State of HCT/Ps

Foley & Lardner LLP on

Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

11 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide