News & Analysis as of

Manufacturers Biotechnology Food and Drug Administration (FDA)

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

Knobbe Martens on

As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Recent FDA Discussion of Artificial Intelligence for Biosimilar Industry

Artificial Intelligence (AI) has long been associated with science fiction movies about dystopian futures, leading to fear among the general public about its potential impact. This is especially the case today for those in...more

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Arnall Golden Gregory LLP

Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or...

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. Some of these clients are interested in studies intended to provide insight into...more

Hogan Lovells

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

Hogan Lovells on

On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

Foley & Lardner LLP

Manufacturing MarketTrends - July 2019, Issue 2

Foley & Lardner LLP on

Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more

Hogan Lovells

Good Manufacturing Practice and the global supply chain

Hogan Lovells on

Supply chain oversight: what to expect from —and how to prepare for— an increasingly global supply chain and heightened FDA scrutiny....more

Benesch

3D Printing and the Renaissance of Local Economies

Benesch on

The rise of 3D printing holds tremendous potential to impact the economy from the local to the national level. Although it is still an estimated five to 10 years away from mainstream consumer adoption, we are already seeing...more

Sheppard Mullin Richter & Hampton LLP

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

King & Spalding

FDA Releases Draft Guidance on Medical Device Reporting - Will Supersede 1997 Guidance

King & Spalding on

On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide