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Healthcare › Drug Safety

MoFo Life Sciences

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

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On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart, in which the court clarified its standards for determining...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Napoli Shkolnik

What Is Polypharmacy And Why Should You Care?

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Polypharmacy is Medspeak for taking more than one prescription medication at a time. About one in five Americans over age 49 is a polypharmicist, of sorts....more

Quarles & Brady LLP

New California Law Affects Pharmacy Operations, Staffing Ratios, And Much More

Quarles & Brady LLP on

On October 8, 2023, California Governor Gavin Newsom signed Assembly Bill 1286 into law. The new law, sponsored by Assemblymember Matt Haney and the California Board of Pharmacy, aims to reduce medication errors and...more

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

Foley Hoag LLP on

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

BakerHostetler

FDA Investigates Children’s Cough and Cold Medication With Codeine Amid Safety Concerns

BakerHostetler on

In the wake of the European Medicines Agency’s (EMA) recently announced warning against giving codeine to children under 12 years old, the FDA announced its own safety investigation of the drug for use in children. The FDA’s...more

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