Tag: AE reporting

Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials

Serious vs Non-Serious Adverse Events: When to Report in Clinical Trials

Learn the critical difference between serious and non-serious adverse events in clinical trials-and when each must be reported. Understand the six FDA criteria, avoid common mistakes, and ensure patient safety without overwhelming the system.

RECENT POSTS

October 23, 2025
Imipramine History: Discovery, Development & Impact

A deep dive into imipramine's discovery, FDA approval, clinical impact, and why it still matters in modern psychiatry.

November 25, 2025
Lower GI Bleeding: Diverticula, Angiodysplasia, and How Doctors Diagnose It

Lower GI bleeding is often caused by diverticula or angiodysplasia, especially in older adults. Learn how doctors diagnose and treat these common but different conditions, and why early intervention matters.

November 16, 2025
How Second and Third Generic Drugs Drive Down Prescription Prices

Second and third generic drug manufacturers drive prescription prices down dramatically-often cutting costs by 50% or more. Learn how competition among generics saves billions and what keeps prices high despite more options.

July 21, 2023
Amlodipine and Cancer: Is There a Link?

In my recent dive into medical research, I stumbled upon a controversial topic: the potential link between Amlodipine, a common high blood pressure medication, and cancer. Several studies have surfaced suggesting a possible association, but the evidence is inconsistent and not yet fully understood. It's essential to remember that correlation does not imply causation, so while this topic definitely warrants further research, there's no need for panic. If you're currently taking Amlodipine, don't stop or change your medication without first discussing it with your doctor. Stay tuned as I continue to monitor this ongoing discussion.

December 9, 2025
Secondary Patents: How Pharmaceutical Brands Extend Market Exclusivity

Secondary patents let pharmaceutical companies extend market exclusivity by patenting minor changes to drugs - not the active ingredient, but how it's delivered, used, or made. These tactics delay generics and keep prices high.