News & Analysis as of

Pregnancy Pharmaceutical Industry

Manatt, Phelps & Phillips, LLP

[Webinar] Improving Access to Care for Pregnant and Postpartum People With Opioid Use Disorder - March 5th, 2:00 pm - 3:00 pm ET

In recent years, drug-related overdoses have become a leading cause of death during pregnancy and the postpartum period, exacerbating a mounting maternal mortality crisis and underscoring the need for improved access to care...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

Lawsuits Filed Against Tylenol, Acetaminophen Manufactures Over Autism, ADHD Link

Lawsuits Filed Against Tylenol, Acetaminophen Manufactures Over Autism, ADHD Link - Parents whose children were born with autism, attention deficit hyperactivity disorder (ADHD), or certain other developmental disorders...more

Console and Associates, P.C.

Several Manufacturers of SSRI Antidepressants Add Warnings of Postpartum Hemorrhaging

Depression during pregnancy, or prepartum depression, is a common condition that an estimated ten percent of women in the United States experience. The development of selective serotonin reuptake inhibitors (“SSRI”) offered...more

Manatt, Phelps & Phillips, LLP

[Webinar] Prenatal Vaccines in Medicaid & CHIP: Current State Payment Rates and Strategies to Increase Access - June 8th, 2:00 pm...

Prenatal vaccines provide important protection for pregnant women and newborns against communicable diseases such as whooping cough and influenza. However, fewer than one out of four pregnant women receives all federally...more

Sheppard Mullin Richter & Hampton LLP

Withdrawal of Drug Approval Highlights Risk of Accelerated Approval Pathway

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

Epstein Becker & Green on

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

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

Foley Hoag LLP

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

Foley Hoag LLP on

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

Foley Hoag LLP

Preparing for Impact: The Mifepristone Case in Texas Nears a Decision

Foley Hoag LLP on

The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more

Faegre Drinker Biddle & Reath LLP

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more

Foley Hoag LLP

Recent Biden Administration Actions on Access to Medication Abortion

Foley Hoag LLP on

In the first week of 2023, the Biden administration announced two actions centered on expanding access to medication abortion. The first involves a policy change by the FDA regarding the ability of retail pharmacies to...more

Console and Associates, P.C.

Parents’ Concerns About the Link Between Acetaminophen and Autism or ADHD

Medications containing Acetaminophen are one of the most commonly used pain relievers worldwide. The chemical compound is an active ingredient in over 600 medicines. For most people, Acetaminophen is benign and can be used to...more

Console and Associates, P.C.

The Use of Depakote by Pregnancy Women Linked to Serious Birth Defects

Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more

Manatt, Phelps & Phillips, LLP

[Webinar] What Will Super Tuesday Mean for Healthcare? - March 2nd, 1:00 pm ET

With healthcare playing such a central role in the election, what could the Super Tuesday results mean for healthcare stakeholders? On March 2—the day before Super Tuesday—Manatt Health will explore these questions in a new...more

Jones Day

FDA Draft Guidance Regarding Inclusion of Pregnant Women in Clinical Trials

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The Situation: Pregnant women have historically been excluded from clinical trials due to concerns about the potential for adverse effects on pregnant women and their fetuses. The Development: The U.S. Food and Drug...more

Hogan Lovells

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

Hogan Lovells on

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #3

Act 188 Plans On Hold as New Chemical Bill is Introduced - Nearly three years after the legislature passed a law to regulate children’s products containing chemicals of high concern, a web site intended to inform the...more

Manatt, Phelps & Phillips, LLP

Manatt on Health Reform: Weekly Highlights - October 2016 #2

Kentucky receives final approval from CMS to transition its Marketplace to the HealthCare.gov platform; Ohio puts a prescription drug price ceiling on its November 2017 ballot; and a new study links Medicaid expansion to...more

Morrison & Foerster LLP - Class Dismissed

Defendants Secure Rare Summary Judgment in Zoloft MDL

In an unusual turn of events, U.S. District Judge Cynthia Rufe recently granted defendants’ motion for summary judgment as to over 300 cases in the Zoloft MDL. These cases were consolidated in 2012 and involved allegations...more

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