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Pharmaceutical Industry Final Rules

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

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The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...more

Epstein Becker & Green

Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ Under Title II of ADA

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To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a long-awaited final rule to improve access to medical diagnostic equipment (MDE) for...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2024 and Beyond

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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more

McGuireWoods Consulting

Washington Healthcare Update - July 2024

This Week in Washington: House Ways and Means Committee marks up healthcare bills related to new technologies and coverage for weight loss drugs; CMS releases CY2025 Home Health and End-Stage Renal Disease PPS proposed rules;...more

Manatt, Phelps & Phillips, LLP

CMS and ONC Issue Final Rule on E-Prescribing

On June 17, CMS and the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule implementing new standards for e-prescribing under Medicare Part D. ...more

Troutman Pepper

FDA Issues Final Rule on Regulation of Laboratory Developed Tests

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After many years of anticipation and various congressional and agency proposals, on May 6, the Food and Drug Administration (FDA) published its final rule titled "Medical Devices; Laboratory Developed Tests." The final rule...more

Jones Day

Canadian Drug Importation May Undermine Intellectual Property Protection

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The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

Venable LLP

Summary of LDT Rule: An In-depth Look at the Final Rule Regarding Laboratory-Developed Tests

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The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more

Quarles & Brady LLP

FDA Publishes Final Rule on Regulation of Lab-Developed Tests

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On May 6, 2024 the FDA published its much-anticipated Final Rule on Lab-Developed Tests (“LDTs”) to make explicit that in vitro diagnostic products (“IVDs”) are devices under the Federal Food, Drug, and Cosmetic Act (“FD&C...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

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Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Venable LLP

The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the...

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On December 26, 2023, the Food and Drug Administration (FDA) issued a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear,...more

Manatt, Phelps & Phillips, LLP

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests

On April 29, the U.S. Food and Drug Administration (FDA) released a final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests (LDTs), subjecting them to the...more

Polsinelli

FDA Finalizes Rule Regulating Laboratory Developed Tests

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FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of...more

Bass, Berry & Sims PLC

The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs

On May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision to increase the FDA’s regulatory oversight of...more

Hogan Lovells

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

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The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more

Quarles & Brady LLP

HHS’ Long-Awaited 340B Alternative Dispute Resolution Rule Is Finalized

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In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

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On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Hogan Lovells

HRSA Issues 340B Program final rule modifying administrative dispute resolution process

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On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative dispute resolution (ADR) process...more

McCarter & English, LLP

New Informed Consent Guidance and Pharmacy Immunity

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more

Jones Day

FDA's Final Device Manufacturing Rule—Not Quite Harmonious With Status Quo

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Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Goodwin

FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

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On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about...more

Manatt, Phelps & Phillips, LLP

Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders

Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more

McGuireWoods Consulting

Washington Healthcare Update - February 2024 #2

This Week in Washington: Senate Finance Committee holds hearing on AI use in healthcare; CMS makes corrections to 2024 Hospital Outpatient Prospective Payment Rates; House passes ban on QALYs....more

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