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FDA Can Keep Tirzepatide off the Drug Shortage List, Judge Says

On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more

Litigation Trends to Watch in 2025

As we welcome 2025, Wilson Sonsini litigators shed light on the emerging trends and key issues they see shaping the legal landscape, from AI regulation to evolving trade secret laws and increasing scrutiny on corporate...more

FDA Announced Removal of Tirzepatide from the Drug Shortage List

On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a declaratory order determining that the shortage of diabetes and weight-loss tirzepatide injection products (Mounjaro and Zepbound; Eli Lilly and...more

FTC Disputes Patent Listings of 10 Brand Drug Makers as Improperly Listed in FDA’s Orange Book

On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more

Federal Circuit Affirms Jazz Pharmaceutical's Risk Evaluation and Mitigation Strategy Patent Is Not Listable in Orange Book

On February 24, 2023, the Federal Circuit held that Jazz Pharmaceuticals, Inc. (Jazz) must delist U.S. Patent No. 8,731,963 (the ’963 Patent) from the U.S. Food and Drug Administration’s (FDA’s) “Orange Book” because the...more

The WSGR Data Advisor - September 2015

In this issue of The WSGR Data Advisor, we examine the FCC’s recent TCPA declaratory ruling and order addressing issues regarding calling and texting consumers, and discuss the new privacy, data security, and transparency...more

HIPAA Omnibus Rule Compliance Deadline

September 23, 2013, the deadline for compliance with the new Health Insurance Portability and Accountability Act (HIPAA) regulations, is here. Although there has been much discussion about the new regulations since they were...more

"Eye on Privacy" Newsletter - May 2013

In this issue: - FTC Issues New Guidance for Disclosures in Online Advertising - European Regulators Opine on "Purpose Limitation" Principle – What Constitutes "Compatible Use" in the Context of Big Data?...more

"Eye on Privacy" Newsletter - January 2013

In this issue: - FTC Releases Final Amendments to Children's Online Privacy Protection Rule - Mobile Apps Face Heightened Privacy Enforcement - Policies and Practices Scrutinized - Global and European...more

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