News & Analysis as of

Reproductive Healthcare Issues Food and Drug Administration (FDA)

Alston & Bird

Health Care Week in Review | Senate Holds Hearings for NIH and FDA Nominees; CMS, HRSA, and SAMHSA Advise Against Forms of...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Robins Kaplan LLP

The Robins Kaplan Justice Report - January 2025

Robins Kaplan LLP on

For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Robins Kaplan LLP

Silent Dangers: The Link Between Depo-Provera, Brain Tumors, and Health Inequities

Robins Kaplan LLP on

For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more

Orrick, Herrington & Sutcliffe LLP

Health Tech Regulatory Trends to Watch in 2025

Republished with Permission In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

Holland & Knight LLP on

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

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...

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

Holland & Knight LLP

Supreme Court Abortion Pill Ruling Doesn't Challenge FDA's Authority

Holland & Knight LLP on

The U.S. Supreme Court on June 13, 2024, unanimously ruled that plaintiffs did not have legal standing to challenge the U.S. Food and Drug Administration's (FDA) actions to establish dosing and availability requirements for...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Unanimously Preserves Access to Mifepristone

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

Fenwick & West LLP

SCOTUS Unanimously Preserves Access to Abortion Pill

Fenwick & West LLP on

On Thursday, June 13, the Supreme Court maintained access to the abortion pill, mifepristone. This medication, in conjunction with misoprostol, was used in nearly two-thirds of all U.S. abortion and miscarriage treatments...more

Epstein Becker & Green

FDA Wins Mifepristone Case, NLRB Denied Lower Injunctive Relief Standards, and “Trump Too Small” Denied Trademark - SCOTUS Today

Epstein Becker & Green on

Of the Supreme Court opinions issued today, the one that will draw the greatest public attention is Food and Drug Administration v. Alliance for Hippocratic Medicine, unanimously holding that the pro-life organizational...more

Jenner & Block

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

Jenner & Block on

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

Dinsmore & Shohl LLP

Supreme Court Rejects Challenge to FDA Regulation of Abortion Medication

Dinsmore & Shohl LLP on

In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the...more

Proskauer - Employee Benefits & Executive...

Supreme Court Rejects Challenge to FDA Approval of Mifepristone: Impact on Health Plans

On Thursday, the U.S. Supreme Court rejected a challenge to the U.S. Food and Drug Administration (FDA) approval of the drug mifepristone, which is used as part of a two-drug protocol to induce abortion. The Court ruled that...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

Fox Rothschild LLP

The 529 Plan Conundrum

Fox Rothschild LLP on

We are entering a strange new world where there are evolving questions about whether assets and rights are federally regulated or state managed. Some of this is traceable to Dobbs v. Jackson Women’s Health, the case that...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

ACA-Required Coverage of Contraceptive Care Remains Agency Focus

Once again, the U.S. Departments of Labor, Health and Human Services, and the Treasury have issued guidance on the Affordable Care Act’s (ACA) required coverage of contraception without cost sharing, clarifying the permitted...more

Foley Hoag LLP - State AG Insights

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

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

Proskauer - Employee Benefits & Executive...

Agencies Update Guidance on Group Health Plan Contraceptive Coverage Requirements

The Departments of Labor, Treasury, and Health and Human Services (the “Departments”) recently issued guidance for group health plans outlining a “therapeutic equivalence” medical management technique for required preventive...more

Mintz - Health Care Viewpoints

White House Launches Initiative on Women’s Health Research

An important new initiative focused on women’s health research – defined as “the study of health across a woman’s lifespan in order to preserve wellness and to prevent, diagnose, and treat disease” – was recently kicked off...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

Hissey, Mulderig & Friend, PLLC

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

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

Dinsmore & Shohl LLP

Fifth Circuit Court Keeps Abortion Medication Legal, But With Restrictions

Dinsmore & Shohl LLP on

The 5th Circuit Court of Appeals in New Orleans upheld parts of a Texas District Court ruling by restricting the use of Mifepristone, while allowing Mifepristone to remain on the market. This is the latest ruling in an...more

Sheppard Mullin Richter & Hampton LLP

Fifth Circuit Rules to Reinstate Abortion Pill Restrictions

Nearly three months after hearing oral arguments, a divided Fifth Circuit panel issued its decision in Alliance for Hippocratic Medicine v. FDA, upholding the U.S. Food and Drug Administration’s (“FDA”) underlying approval of...more

Sheppard Mullin Richter & Hampton LLP

FDA Approves First Over-the-Counter Daily Oral Contraceptive

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

FDA Warns “Natural” Birth Control Company: Three Takeaways from the NOV Letter

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this...more

56 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide