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Healthcare › Food and Drug Administration (FDA) › Reproductive Healthcare Issues

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Akerman LLP - Health Law Rx on

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Unanimously Preserves Access to Mifepristone

Sheppard Mullin Richter & Hampton LLP on

In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

Foley Hoag LLP - State AG Insights

State Attorneys General Weigh in Amidst Supreme Court Case That Could Restrict Access to Abortion Drug Mifepristone

Foley Hoag LLP - State AG Insights on

Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more

Knobbe Martens

First At-Home Artificial Insemination Kit Receives FDA Clearance

Knobbe Martens on

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

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

Manatt, Phelps & Phillips, LLP on

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Hissey, Mulderig & Friend, PLLC

Thousands of Women Report Paragard Copper IUDs Broken During Removal, FDA Data Shows

Hissey, Mulderig & Friend, PLLC on

Federal health officials have received thousands of reports of women whose Paragard copper IUDs broke when they were being removed. Hundreds of women with broken Paragard IUDs have filed lawsuits against the manufacturers of...more

Manatt, Phelps & Phillips, LLP

5th Circuit Rejects FDA Actions Expanding Access to Medication Abortion; Supreme Court Review Likely

Manatt, Phelps & Phillips, LLP on

On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more

Sheppard Mullin Richter & Hampton LLP

FDA Approves First Over-the-Counter Daily Oral Contraceptive

Sheppard Mullin Richter & Hampton LLP on

On July 13, 2023, the Food and Drug Administration (“FDA”) approved the first daily contraceptive for use without a prescription. Opill® (norgestrel) tablet, .075 mg has been approved to prevent pregnancy in individuals of...more

Mintz - Health Care Viewpoints

First Nonprescription Birth Control Pill Approved for Marketing by FDA: A Milestone for Reproductive Health

Mintz - Health Care Viewpoints on

As we previously reported, Perrigo Company’s subsidiary HRA Pharma submitted an application to the Food and Drug Administration (FDA) in the summer of 2022 to switch an existing prescription-only progestin birth control pill...more

Foley & Lardner LLP

Reproductive Health: Over the Counter Birth Control Pill Supported by FDA Advisory Committees

Foley & Lardner LLP on

At the May 9-10, 2023, Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee, U.S. Food and Drug Administration (FDA) advisers voted that the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Privacy & Cybersecurity Update - April 2023

Skadden, Arps, Slate, Meagher & Flom LLP on

In this month’s Privacy & Cybersecurity Update, we look at Washington state’s passage of the first-ever state-level health data privacy law and the finalized California Consumer Privacy Act regulations. We also examine a...more

Dinsmore & Shohl LLP

Contradictory Court Opinions Leave the Approval of Abortion Medication in Question

Dinsmore & Shohl LLP on

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

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