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FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

Complete Response Letter, Warning Letter and Shareholder Lawsuit Follow FDA Data Integrity Findings

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more

Certain Stem Cell Products Require FDA Premarket Approval

On September 27, 2024, in USA v. California Stem Cell Treatment Center, Inc., the US Court of Appeals for the Ninth Circuit issued a decision agreeing with the US Food and Drug Administration (FDA) that the defendants’ stem...more

FDA Finalizes Guidance on Use of Part 11 Electronic Systems, Records and Signatures in Clinical Investigations

On October 1, 2024, the US Food and Drug Administration (FDA) finalized its guidance on the use of electronic records in clinical investigations of drugs, devices, biologics, foods, tobacco products and new animal drugs. The...more

Artificial Intelligence/Machine Learning Medical Device Regulatory Handbook

Even before the Biden administration issued a landmark executive order on October 30, 2023, establishing new standards for artificial intelligence (AI) safety and security, the US Food and Drug Administration (FDA) had been...more

FDA's Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more

US CMS Announces Initial Prices for Medicare Drug Price Negotiation Program

On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more

US Supreme Court’s October 2023 Term Administrative Law Trilogy – Holdings, Analyses and Implications of Jarkesy, Loper Bright and...

The October 2023 term of the US Supreme Court (SCOTUS) saw a trilogy of decisions that challenge long-settled assumptions about the authority of federal agencies and upend long-standing doctrines of administrative law: SEC v....more

FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). By issuing this rule, FDA amended the medical device current good...more

Proceed With Caution: Federal Courts of Appeal Uphold Criminal Convictions for Misbranding Violations Under FDCA

Voluntary compliance may be the backbone of the Federal Food, Drug, and Cosmetic Act (FDCA), but when the US government believes that a company is unwilling or unable to achieve compliance, it will seek to enforce the FDCA...more

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more

Proposed Rule on Laboratory-Developed Tests Takes Center Stage

The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more

FTC Revises Health Products Compliance Guidance

In December 2022, the Federal Trade Commission released its Health Product Compliance Guidance, updating and replacing its 1998 industry advertising guidelines on dietary supplements. Unlike the 1998 guidelines, the new guide...more

FDORA’s Changes to the FDA Accelerated Approval Program

Enacted on December 29, 2022, the Consolidated Appropriations Act (the year-end omnibus spending bill) includes the Food and Drug Omnibus Reform Act (FDORA), which enhances the Food and Drug Administration’s authority in...more

FDA Doubles Down on Its Pre-Catalyst Stance on Orphan Drug Exclusivity

On January 24, 2023, the Food and Drug Administration published a notice in the Federal Register to “address the uncertainty” created by the US Court of Appeals for the Eleventh Circuit’s September 30, 2021, decision in...more

FDA Regulatory Framework for Cosmetics Gets Major Overhaul

Enacted on December 29, 2022, as part of the 2023 omnibus bill, the Modernization of Cosmetics Regulation Act (MoCRA) is a major overhaul of the Food and Drug Administration’s current regulatory framework for cosmetics. MoCRA...more

FDA’s Latest Twist on Digital Health Oversight Brings Big Shift

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more

FDA Unveils Considerations for Rescinding Breakthrough Therapy Designation

On June 24, 2022, the US Food and Drug Administration issued a draft guidance document on the Considerations for Rescinding Breakthrough Therapy Designation. The guidance explains how the FDA may rescind a drug or biologic...more

US Supreme Court to Review Department of Justice Dismissal Authority

On June 21, 2022, the Supreme Court agreed to review a US Court of Appeals for the Third Circuit decision holding that the federal government’s ability to dismiss False Claims Act (FCA) lawsuits is controlled by Federal Rule...more

FDA Releases Draft Guidance on Development of Genome Editing and CAR T Therapies

On March 15, 2022, the US Food and Drug Administration issued a pair of draft guidance documents in the gene therapy space. The first, which is specific to gene therapies incorporating genome editing (GE), was aimed at...more

DOJ Previews Enforcement Policies Aimed at Clinical Trial Fraud

On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more

Department of Justice Announces Significant Changes to Corporate Criminal Enforcement

Overview Last week, the #2 official at the Department of Justice announced significant new measures intended to strengthen the DOJ’s response to criminal corporate misconduct. In an address to the ABA’s National Institute on...more

Alert: What’s at Steak: USDA Solicits Comments on Cultured Meat Labels

Using recent advances in cell culture technology, numerous companies are developing meat products produced in vitro using cultured cells derived from living animals. As such companies get ready to market their products to...more

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