Marissa Hill Daley on Pharmaceutical Industry

Off-Label Communications Back in the Spotlight at the FDA

For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more

11/6/2023 / Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Telemedicine

U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances

The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics....more

10/5/2023 / Biologics , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight

Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration

In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more

10/3/2023 / Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Healthcare Reform , Manufacturers , Medical Devices , Medical Software , Pharmaceutical Industry , Prescription Drugs , Software

FDA Cracks Down on Unapproved Eye Products

On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more

9/19/2023 / Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Labeling , Manufacturers , Medical Devices , Personal Care Products , Pharmaceutical Industry , Product Labels

HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

9/6/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program

Almost 11 months after President Biden signed the Medicare Drug Price Negotiation Program (“Negotiation Program”) into law, the Centers for Medicare and Medicaid Services (CMS) has issued revised guidance that clearly details...more

7/13/2023 / Biden Administration , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Medicaid , Medicare , Pharmaceutical Industry , Prescription Drugs

U.S. Supreme Court Closes Door on Objective Reasonableness Defense in Healthcare False Claims Act Cases

Leaves Window Open for Defense Based on Subjective Belief - On June 1, 2023, the U.S. Supreme Court issued a decision in a consolidated appeal of two healthcare qui tam cases that removes a very powerful defense from...more

6/9/2023 / Drug Pricing , False Claims Act (FCA) , Healthcare , Pharmaceutical Industry , Pharmacies , Prescription Drugs , Reasonable Interpretations , Safeco , Safeco Insurance Co of America v Burr , Scienter , SCOTUS , US ex rel Thomas Proctor v Safeway Inc , US ex rel Tracy Schutte et al v SuperValu Inc et al

Marissa Hill Daley

Wilson Sonsini Goodrich & Rosati

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