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Pharmaceutical Industry › FDA Approval › Reproductive Healthcare Issues

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

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On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

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Mosie Baby, a Texas-based fertility care company, has received clearance from the U.S. Food and Drug Administration for its over-the-counter intravaginal insemination kit.  The kit was developed for those who are unable to...more

Knobbe Martens

Supreme Court Issues Stay in Mifepristone Case, Preserving Status Quo for Now

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On April 21, 2023, the Supreme Court granted a stay in Alliance for Hippocratic Medicine v. FDA, a case concerning the Food and Drug Administration’s approval of and access to the widely used abortion pill mifepristone. The...more

Sheppard Mullin Richter & Hampton LLP

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

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On April 5, 2023, the U.S. Food and Drug Administration (“FDA”) announced its decision to withdraw the approval of Makena® hydroxyprogesterone caproate injection (“Makena”) – a drug that was approved in 2011 to reduce the...more

Epstein Becker & Green

The Legal Battle Over Mifepristone

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During the past several turbulent weeks for the U.S. health care system, rulings in the case Alliance for Hippocratic Medicine v. FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific...more

Dinsmore & Shohl LLP

Contradictory Court Opinions Leave the Approval of Abortion Medication in Question

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On April 7, 2023, two federal judges in Texas and Washington State issued dueling opinions about the abortion medication Mifepristone, just hours apart. These two decisions come in the midst of growing tension about abortion...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...

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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

Foley Hoag LLP

Mifepristone Update: Texas Judge Probes Extent to Which Court Can Affect the FDA’s Approval

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Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more

Patrick Malone & Associates P.C. | DC Injury...

A reckoning for FDA fast drug approvals and moms’ mistreatment

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Federal regulators have hit a highly public reckoning for their policies to provide speedy approvals for prescription drugs, benefiting Big Pharma’s profits but not necessarily patients — notably women in serious need of help...more

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