Parker Waichman LLP

FDA to Consider Kidney Toxicity Biomarkers in Drug Approval

  FDA Accept Biomarkers in Drug Approval Process. The Food & Drug Administration (FDA) has decided to allow data for seven kidney toxicity biomarkers as part of the drug approval process. Both the FDA and the European Medicines Association (EMA) have agreed to accept the biomarker data, making it the first use of a framework allowing submission […]

Drug Approval Process

 

FDA Accept Biomarkers in Drug Approval Process. The Food & Drug Administration (FDA) has decided to allow data for seven kidney toxicity biomarkers as part of the drug approval process. Both the FDA and the European Medicines Association (EMA) have agreed to accept the biomarker data, making it the first use of a framework allowing submission of a single application to the two agencies.

A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can be used to detect dangerous drug side effects.

Ultimately, the pharmaceutical industry would like to see the FDA adopt a range of such biomarker tests for human clinical trials that would signal dangerous side effects like heart failure, liver damage or cancer.

Human clinical trials

Under current testing protocols, experimental drugs are subjected to animal testing before they can move on to human clinical trials. But animal tests aren’t always the best predictor of whether substances will be safe for humans. For example, if a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.

Under a biomarker protocol, samples of blood, urine or saliva, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.

To date, both the FDA and EMEA have required drug companies to submit the results of two blood tests — blood urea nitrogen and serum creatinine — to evaluate renal toxicity. Now, in addition to those tests, the agencies will accept results from the seven biomarker-based tests as part of the drug-review process.

The FDA and EMEA will now accept the results of tests that measure the levels of seven proteins found in urine that are indicative of drug-induced damage to kidney cells.  Drug makers are not required to collect this biomarker data, but if they do, “it must be submitted to FDA,” the agency said.

Need Legal Help Regarding Drug Approval Process?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Michele Josama an employee of Parker Waichman LLP provided excellent service. She is qualified, competent, and caring. Further, the attorney assigned to my case was available to provide updates and kept me informed. Without a doubt, I would highly recommend Parker and Waichman LLP.
Dr. R
3 years ago
5 Star Reviews 150
I am happy to choose Parker Waichman to handle my case. They are very professional and attentive, they always answer any questions I have. I also thank Denny Tang, Kathy Núñez and Jorge Peniche for making me feel comfortable with their help. Thank you for everything you are doing for me.
Francisco Aviles
5 years ago
5 Star Reviews 150
I highly recommend Parker Waichman. Their staff Ashley, Jorge and Gina are very professional. I was really happy with their service.
Tonia Bailey
4 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038