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Non-Disclosure Agreement Food and Drug Administration (FDA)

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - September 2024

Silence surrounding medical harms hurts patients and the medical care system - An ugly truth of 21st century medicine is that episodes that hurt and kill patients get hidden from public view in the name of patient...more

McDonnell Boehnen Hulbert & Berghoff LLP

H. Lundbeck A/S v. Lupin Ltd. (Fed. Cir. 2023)*

The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past...more

Axinn, Veltrop & Harkrider LLP

FTC Throws Down the Gauntlet on Improper Orange Book Listings

The FTC recently issued a policy statement warning drug manufacturers that it “intends to scrutinize improper Orange Book listings” and “use its full legal authority” to “tak[e] actions against companies and individuals that...more

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

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Foley & Lardner LLP

Food & Beverage Supply Chain Desk Reference

Foley & Lardner LLP on

Foley & Lardner’s Food & Beverage Industry Team has authored a new handbook entitled, “Food & Beverage Supply Chain Desk Reference.” For the sake of convenience, the Desk Reference includes quick answers to your legal needs...more

Patrick Malone & Associates P.C. | DC Injury...

Courts, by too readily sealing records, contributed to opioid crisis, report finds

The blame and shame for the opioid-drug overdose crisis that kills tens of thousands Americans annually has moved to yet another set of individuals and institutions now — judges and courts that handled Big Pharma lawsuits and...more

Foley & Lardner LLP

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

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