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Morgan Lewis - As Prescribed

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

Morgan Lewis - As Prescribed on

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill in Limbo: Navigating the Intricacies of Conflicting Federal Court Rulings in Texas and Washington State

Sheppard Mullin Richter & Hampton LLP on

The U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, has been curtailed following dueling federal court decisions in Texas and Washington. Just days after a Texas...more

BakerHostetler

Challenge to the FDA's Approval of Abortion Medication

BakerHostetler on

On Friday, April 7, both the Northern District of Texas and the Eastern District of Washington issued decisions impacting the Food and Drug Administration’s (FDA) approval of the abortion drug mifepristone. The Texas decision...more

Goodwin

A Tale of Two Lawsuits: Federal Court in Texas Suspends FDA Approval of Medication Abortion Drug Mifepristone Nationwide, While...

Goodwin on

The US Supreme Court’s June 2022 decision in Dobbs v. Jackson Women’s Health Organization — which overturned Roe v. Wade and nearly 50 years of a federal constitutional right to abortion — has had a tectonic impact. Less than...more

Quarles & Brady LLP

FDA REMS Protocol Modification Provides a Pathway for Pharmacies to Dispense Mifepristone

Quarles & Brady LLP on

On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more

Faegre Drinker Biddle & Reath LLP

FDA’s Final Guidance: “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals,...

Faegre Drinker Biddle & Reath LLP on

The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more

Hogan Lovells

FDA Simplifies and Clarifies Expanded Access Program

Hogan Lovells on

Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment...more

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