FDA

FDA Issues Warning About Probiotics Sold for Preterm Infants

by Veronica Salib

On October 26, 2023, the United States Food and Drug Administration (FDA) issued a press release raising concerns about probiotics sold for preterm infants. The organization has sent letters to...

FDA Reviews AstraZeneca’s Self-Administered Flu Vaccine, FluMist

by Alivia Kaylor

In a landmark development in the world of healthcare, AstraZeneca's FluMist Quadrivalent is set to revolutionize flu vaccination by potentially becoming the first and only self-administered flu...

FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain

by Veronica Salib

Earlier this week, Hyloris Pharmaceuticals, a pharmaceutical company headquartered in Belgium, announced the approval of a potent non-opioid painkiller in the United States. The US Food and Drug...

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...

A Look at California’s Newest Bans on Chemicals in Food

by Veronica Salib

On October 7, 2023, California Governor Gavin Newsom signed a bill prohibiting the manufacturing, sale, delivery, distribution, or carrying of food products for human consumption containing four presumably harmful chemicals: brominated...

Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings

by Veronica Salib

Last week, the United States Food and Drug Administration (FDA) issued two warning letters to online vendors selling unauthorized versions of semaglutide and tirzepatide, active ingredients in...

10 Things to Know About the Updated 2023 COVID-19 Vaccines

by Alivia Kaylor

With the onset of the fall season, many Americans are grappling with numerous questions about COVID-19 booster shots, the flu vaccine, and respiratory syncytial virus (RSV) protection. This year's vaccine rollout has encountered...

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On October 4, 2023, the United States Food and Drug Administration (FDA) released a draft guidance titled Stimulant Use Disorders: Developing Drugs for Treatment.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

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

Pediatric Amoxicillin Shortage Persists as Winter Approaches

by Veronica Salib

With October approaching, it has been nearly one year since the start of the amoxicillin shortage. According to the United States Food and Drug Administration (FDA), the deficiency was first identified...

How Do Various Stakeholders Define Clinically Meaningful Data?

by Veronica Salib

Defining clinically meaningful data can be complicated, as different stakeholders may have variable definitions depending on their demographics, needs, and perspectives. Understanding how various stakeholders may define clinically...

FDA Issues Warning Letters for Marketing Unapproved Ophthalmic Drugs

by Veronica Salib

On September 12, 2023, the United States Food and Drug Administration (FDA) issued warning letters to eight companies, including Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc,...

CDC Recommends Updated COVID-19 Boosters This Fall/Winter

by Veronica Salib

Yesterday, the United States Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss updated COVID-19 booster recommendations for the...

CDC Updates Recommendations for Pneumococcal Vaccine for Adults

by Veronica Salib

In a Morbidity and Mortality Weekly Report (MMWR) from the United States Centers for Disease Control and Prevention (CDC), public health experts updated pneumococcal vaccination recommendations for...

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...

FDA Issues 15 Warning Letters to Online Retailers Selling E-Cigarettes

by Veronica Salib

On August 23, 2023, the United States Food and Drug Administration distributed 15 warning letters to online retailers selling or distributing illegal and unauthorized e-cigarettes that appeal to...

Dissecting Ethical Principles in the Pharmaceutical Industry

by Veronica Salib

According to the Seven Pillars Institute for Global Finance and Ethics, various ethical issues are pressing the pharmaceutical industry and its stakeholders, including researchers, pharmacists, pharmaceutical companies, other healthcare...

CDC Follows Listeria Outbreak After Ice Cream Recall

by Veronica Salib

On August 22, 2023, the Centers for Disease Control and Prevention published additional information on a Listeria outbreak linked to a recent food recall. Earlier that month, the United States Food and...

More Eyedrops Recalled Due to Bacterial, Fungal Contamination

by Veronica Salib

On August 22, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers on two methylsulfonylmethane (MSM) eyedrops, reporting bacterial and fungal contaminations as the...

FDA Approves RSV Vaccine for Pregnant Individuals as Prevention Tool

by Veronica Salib

On August 21, 2023, the United States Food and Drug Administration (FDA) approved Abrysvo, a respiratory syncytial virus (RSV) vaccine. The drug aims to prevent illness in infants under six months by...