Inside the FDA’s Quiet Move to Weaken Drug Approval Standards
The Food and Drug Administration (FDA) is preparing to reduce the default number of clinical trials it will require to approve new drugs, a shift…
Dec 17, 2025
Menu
Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications
Drug Safety
Hormone Therapy Just Lost Its Black Box Warning. Now the FDA Owes Women Clarity
You likely saw a wave of coverage last week about the FDA removing the agency’s strongest safety alert – the so-called Black Box warning –…
Nov 18, 2025
What’s Really Inside Your OTC Drugs? We Don’t Actually Know, And Here’s Why
When you look up a prescription drug like atorvastatin — a cholesterol-lowering medication sold under the brand name Lipitor — in the FDA’s Orange Book, you’ll…
Nov 19, 2025
What to Know About Lynkuet, the New Hot Flash Drug
On October 24, 2025, the U.S. Food and Drug Administration (FDA) approved Lynkuet (elinzanetant), a non-hormonal medication designed to reduce hot flashes and improve sleep in women…
Dec 2, 2025
When the Neighborhood Pharmacy Closes, ‘Everything Changes’
Community pharmacists (those who work in retail pharmacies) are uniquely qualified to provide fast, accurate, and reliable medication advice. And pharmacists have long been regarded…
Nov 10, 2025
Zyn and Nicotine: What You Don’t Know Might Hurt You
With two young kids at home and a yearning to live healthier, 38-year-old Ian P. decided in January 2025 to kick his long-time smoking and…
Oct 16, 2025
Will Taking Tylenol During Pregnancy Harm Your Baby? The Evidence Is Complicated
Editor’s Note: On November 10, 2025, the BMJ published a new meta-analysis reviewing existing studies on the links between acetaminophen use in pregnancy and ADHD or autism…
Sep 25, 2025
Drug Recalls in America: How They Work, Where They Fail, and How You Can Protect Yourself
On June 27, 2024, Mary Louise Cormier, age 91, was admitted to the MaineHealth Mid Coast Hospital Emergency Department in Brunswick, Maine, after showing signs of lethargy…
Aug 27, 2025
The FDA’s Drug Adverse Event Database Is Now Updated in Real Time: Here’s How to Use It
On Friday, August 22, the Food and Drug Administration (FDA) announced in a press release that it would begin updating its Adverse Events Reporting System (FAERS) in…
Aug 25, 2025
What Is Step Therapy? And Why It Might Delay Your Medication
Navigating the healthcare system to get the care you or a loved one needs can be challenging. Just when you think you’ve cleared the hardest…
Jul 21, 2025
Why Pharmacies Are Disappearing, And What We Lose When They Do
From 18th-century apothecaries to modern drive-thru drug stores, pharmacies have evolved in form, but their central purpose has stayed constant: They serve as community centers…
Jun 24, 2025
Medical Journals Have Flaws, But Government Oversight Isn’t the Fix
Robert F. Kennedy Jr., Secretary of Health and Human Services (HHS), has floated an old idea as a new proposal – he wants to ban…
Jun 13, 2025
Unannounced Inspections of Drug Manufacturers Could Improve Drug Safety — If It Actually Happens
On May 5, 2025, President Trump issued an executive order aimed at increasing domestic medication production. In addition to removing regulatory barriers for domestic manufacturers, the order…
Jun 10, 2025
Controlled Drug Classifications: Schedule I, II, III, IV, V
Since the early 1900s, the federal government has attempted to regulate narcotics and other drugs with a potential for abuse or dependence (whether for medical or recreational…
May 8, 2025
Mission Critical Update: Medication Safety Updates from the FDA Delayed
For a few months now, our writer Katie Rowley has been making sense of the Food and Drug Administration’s (FDA) updates on drug safety for MedShadow readers…
Apr 24, 2025
Makary’s “Blind Spots” Offers Big Ideas — But Can He Deliver as FDA Commissioner?
With Marty Makary, M.D., now leading the Food and Drug Administration (FDA), I picked up his latest book, Blind Spots, hoping to gain some insight into the…
Apr 11, 2025
Journavx: How Safe Is This New FDA-Approved Painkiller?
On January 30, 2025, the Food and Drug Administration (FDA) approved a new drug for short-term pain relief, with both the agency and its manufacturer claiming…
Mar 17, 2025
Opinion: RFK’s “Radical Transparency” Looks More Like A Closed Door
When Robert F. Kennedy Jr., the newly appointed head of U.S. Health and Human Services (HHS), promised an era of “radical transparency” on February 13th, many…
Mar 13, 2025
Medication Safety For Older Adults: Strategies To Reduce Risk And Improve Care
Each year, an estimated 1.5 million people in the U.S. are affected by medication errors. Older adults face an even greater risk due to the challenges of juggling multiple…
Mar 12, 2025
The FDA’s New Drug Ad Rules Are Here. Will They Actually Change Anything?
On May 20, 2024, a new set of rules designed by the Food and Drug Administration (FDA) to improve clarity in medication advertising went into effect. The…
Mar 3, 2025
