Policy and Regulation

Abbott provided $650,000 to FDA advisory panel members

April 11, 2024 - How should regulatory bodies and consumers weigh payments made by life sciences companies to FDA advisory panel members? That’s the question posed by the recent news that 10 of 14 voting members on the United States FDA advisory board for the Abbott TriClip G4 System received payments from Abbott between 2016 and 2022. Based on their...

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Rising adult melatonin use sparks concern over unsupervised child exposure

by Alivia Kaylor

In recent years, while melatonin use among adults in the United States has surged due to heightened awareness of sleep disorders and interest in natural remedies, a concerning trend has emerged:...

Revolutionizing Vaccine Storage and Distribution with Innovative Solutions

by Alivia Kaylor

The global COVID-19 pandemic has highlighted the critical role of vaccines in controlling the spread of infectious diseases. As the demand for vaccines continues to rise, developing innovative solutions for their storage and distribution...

Online Pharmacies Under Scrutiny for Lax Safety Checks, Endangering Patients

by Alivia Kaylor

In a groundbreaking investigation, the BBC uncovered a concerning trend in the online pharmaceutical industry, where prescription-only medicines are sold without adequate checks. The report exposes a...

FDA Launches New Advisory Committee for Genetic Metabolic Diseases

by Veronica Salib

Adding to the lengthy list of advisory committees under its belt, the United States Food and Drug Administration (FDA) announced its plans to create a new advisory committee to specialize in genetic...

Price Transparency Healthcare Policies Reduce Out-Of-Pocket Costs

by Editorial Staff

Price transparency enables patients to shop for the most effective and inexpensive healthcare available and is vital as patient out-of-pocket healthcare costs continue to skyrocket year-over-year.   A 2021 Kalorama Information...

How to Effectively Integrate AI into Clinical Trials

by Veronica Salib

Since its inception, artificial intelligence (AI) has continually disrupted practices across all industries. As more and more healthcare researchers and clinicians adopt AI, experts have noted the impact of AI on clinical research and...

FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales

by Veronica Salib

On November 13, 2023, the United States Food and Drug Administration (FDA) publicly published a warning letter issued to Andrew Jassy, CEO of Amazon.com, identifying violations in seven...

What to Know About the 2023 Eyedrop Recalls, Understanding the Risks

by Veronica Salib

On February 2, 2023, the first of three eyedrops in the United States were recalled voluntarily after multiple reports of illness associated with the drops were reported to the CDC. Since then, two additional eye drops in the US...

Understanding the Dangers of Nutraceuticals and Dietary Supplements

by Veronica Salib

Throughout the past few decades, the healthcare industry has seen the emergence of a new class of treatments: nutraceuticals. A cross between nutrition and pharmaceuticals, the term nutraceutical was coined by Stephen DeFelice, MD, in...

FDA Proposes Ban on Formaldehyde Hair Smoothing, Straightening Products

by Veronica Salib

A proposed rule by the United States Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) has proposed banning hair products that contain formaldehyde or...

Ensuring Drug Safety Through Regulatory Compliance

by Alivia Kaylor

In healthcare technology, the intersection of science and regulations is where innovation meets responsibility. Nowhere is this more evident than in the pharmaceutical industry, where drug safety is paramount. Regulatory compliance plays a...

FDA Updates Infant Formula Compliance Program

by Veronica Salib

To minimize the risk of contaminated infant formula, the United States Food and Drug Administration (FDA) updated its infant formula compliance program, announcing the changes on October 6, 2023. Last...

FDA Issues Guidance on Drug Development for Stimulant Use Disorders

by Veronica Salib

On October 4, 2023, the United States Food and Drug Administration (FDA) released a draft guidance titled Stimulant Use Disorders: Developing Drugs for Treatment. The recommendations suggest protocols...

CDC Recommends Doxycycline PEP to Prevent STIs

by Veronica Salib

Earlier this week, the Centers for Disease Control and Prevention (CDC) published a draft guidance for the use of doxycycline, a common antibiotic, as a post-exposure prophylaxis (PEP) treatment to...

HHS Petitions DEA to Reclassify Cannabis as a Schedule III Drug

by Veronica Salib

On August 30, 2023, a leaked document revealed that the United States Department of Health and Human Services (HHS) plans to petition the Drug Enforcement Administration (DEA) to reclassify cannabis...

First FDA-Approved Biosimilar for Multiple Sclerosis Mimics Tysabri

by Veronica Salib

On August 24, 2023, the United States Food and Drug Administration approved Tyruko, natalizumab-sztn, a biosimilar for Tysabri (natalizumab), an injectable biologic for managing multiple sclerosis. The...

Understanding Pharmaceutical Drug Addiction: Types, Signs, Treatments

by Veronica Salib

Drug addiction and treatment have become an increasingly serious problem in the United States healthcare system. Substance use disorders are life-threatening mental illnesses that continue to take lives, alter families, and burden...

White House National Response Plan Addresses Xylazine, Fentanyl Risk

by Veronica Salib

A statement issued by the White House on July 11, 2023, outlined a national response plan to address the ongoing risk of fentanyl laced with xylazine. As more illicit drug overdoses are linked to...

45% of Drinking Water Samples in the United States Contain PFAS

by Veronica Salib

An analysis of 716 tap-water samples revealed that 45% of drinking water samples in the United States contained at least one tested per- and poly-fluoroalkyl substance (PFAS), also called forever...

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