Marissa Hill Daley

Marissa Hill Daley

Wilson Sonsini Goodrich & Rosati

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OIG Tackles New Issues in Its General Compliance Program Guidance: What Companies Need to Know

On November 6, 2023, U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a General Compliance Program Guidance (GCPG) as part of its plan to renovate its library of compliance program...more

11/20/2023  /  Compliance , Department of Health and Human Services (HHS) , Health Care Providers , Healthcare , Healthcare Facilities , Hospitals , Inspector General , Stark Law

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For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more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

FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in...more

10/6/2023  /  Clinical Laboratories , Diagnostic Tests , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Proposed Rules

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In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.”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10/3/2023  /  Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Healthcare Reform , Manufacturers , Medical Devices , Medical Software , Pharmaceutical Industry , Prescription Drugs ,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

California Prepares First-of-Its-Kind Food Additive Ban in the United States

Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023....more

9/19/2023  /  Additive Manufacturing , California , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Food Safety , Food Supply , New Legislation , Public Health

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

Cannabis Summer Recap: Potential Rescheduling, Congressional Requests for Information, and Enforcement Activity

Summer 2023 saw dynamic executive, legislative, and enforcement activity in the cannabis and cannabidiol space. While the U.S. Department of Health and Human Resources (HHS) took steps to reschedule cannabis as a Schedule III...more

9/15/2023  /  Cannabis Products , Cannabis-Related Businesses (CRBs) , Decriminalization of Marijuana , Department of Health and Human Services (HHS) , Dispensaries , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marijuana , Marijuana Cultivation , Marijuana Related Businesses

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

Next Step for Cosmetic Products' Regulatory Makeover

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on new requirements for registration and listing of cosmetic product facilities and products. The draft guidance follows the signing of the...more

8/18/2023  /  Cosmetics , Food and Drug Administration (FDA) , Health and Safety , Manufacturers , Modernization of Cosmetics Regulation Act of 2022 (MoCRA) , New Legislation , Personal Care Products , Product Labels , Product Safety Labels

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

CMS Proposes a Novel Replacement for Rescinded Pathway to Expedited Reimbursement of Breakthrough Devices

In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients. CMS has strived...more

6/29/2023  /  Centers for Medicare & Medicaid Services (CMS) , Emerging Technologies , Health Care Providers , Healthcare , Hospitals , Medicaid , Medicare , Physicians

Lab to Table Dining—Coming Soon to a Kitchen Near You

Last week, the U.S. Department of Agriculture (USDA) issued grants of inspection to two companies, allowing them to begin producing and selling cell-cultivated chicken meat to consumers—a first in the U.S. This marks the end...more

6/29/2023  /  Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Genetically Engineered Animals , Public Health , USDA

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

FDA Accelerates Approval of Animals with Investigational Intentional Genomic Alterations (IGAs)

The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is advancing ahead in growing the regulatory landscape for developers and sponsors of animals with investigational intentional genomic...more

6/6/2023  /  Agribusiness , Bioengineering , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , Genetically Engineered Animals , USDA

Medicare Contractors Buy Additional Time for the Digital Health Industry

The explosive growth in telehealth over the past five years has resulted from, among other things, the Centers for Medicare & Medicaid Services’ (CMS) extension of Medicare reimbursement to remote monitoring of patients by...more

6/1/2023  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Medical Reimbursement , Medicare , Medicare Administrative Contractors (MAC) , Telehealth , Telemedicine

FDA Passes the Buck (Back) to Congress for Legislative Solution on CBD Regulation

While the state of the U.S. Food and Drug Administration’s (FDA’s) regulation of Cannabidiol (CBD) remains gray, the agency now sees a path forward through federal legislation. Here’s what companies in the cannabis industry...more

5/16/2023  /  Cannabidiol (CBD) oil , Congressional Investigations & Hearings , Dietary Supplements , Food and Drug Administration (FDA) , Health and Safety , Plant Based Products , Regulatory Oversight

HHS OIG Announces Modernization of Compliance Program Guidance Documents

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is continuing its long-laid plans to update its existing compliance program guidance documents (CPGs). On April 24, 2023, OIG...more

5/1/2023  /  Department of Health and Human Services (HHS) , Fraud and Abuse , Health Care Providers , Healthcare , Hospitals , OIG , Physicians
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