---
title: Oncology Drug Approval Process
description: Sometimes, the U.S. FDA is criticized as incapable in comparison with its European counterpart, the EMEA.
---
×
[](https://td2inc.com/)
[](https://td2inc.com/)
[Regulatory](https://blog.td2inc.com/tag/regulatory)
# Oncology Drug Approval Process
September 18, 2018
> Sometimes, the U.S. FDA is criticized as incapable in comparison with its European counterpart, the EMEA. Particularly this criticism is commonly found in the field of oncology, where highly sick patients have little options for treatment. But now, the FDA is getting their hands on essential therapeutic medications faster than their European counterpart.
The latest study shows that 23 cancer drugs were approved in both the Europe and U.S. The U.S. was the first to do this oncology drug approval.
**Laws and Regulations of Oncology Drugs**
The objective of the FDA is to safeguard the pocketbook, safety and health of the consumers. The basic food and drug law of the U.S. is the Federal Food, Drug and Cosmetic Act. With a lot of amendments, this is the most expansive law of its type on the globe.
This law is applied for assuring consumers that foods are safe for eating, pure and wholesome and made under healthy and sanitary processes. It also ensures that devices and drugs are secure, effective and safe for their applied uses. The FDA also ensures that food and drug packaging and labeling is informative, truthful and not deceptive. It also assures cosmetics are safe and made from proper materials.
**Timeline From Oncology Drug Development to Approval**
In the U.S., the FDA’s Center for Drug Evaluation and Research (CDER) is the prime consumer watchdog. Its main task is to evaluate new drugs prior to allowing them to be sold. This evaluation stops deceitfulness on the part of the drug manufacturer, and also offers patients and doctors the data they require for using the medicines properly. CDER makes sure these drugs work as intended and don’t carry any unknown health risks.
In the U.S., the drug agencies first test the drugs before selling them. Even the team of CDER chemists, doctors and pharmacologists evaluate the information and packaging of the product. If they find everything perfect with health advantages, the drug is approved for sale. The same [oncology drug approval process](https://td2inc.com/submission-and-specialty-filing/) goes to the sponsors, also.
- [Advancing Bone and Sarcoma Cancer Research Through Robust In Vivo Models](https://blog.td2inc.com/advancing-bone-and-sarcoma-cancer-research-through-robust-in-vivo-models)
- [How the FDA’s Plausible Mechanism Framework Signals the Future of Precision Oncology](https://blog.td2inc.com/how-the-fdas-plausible-mechanism-framework-signals-the-future-of-precision-oncology)
- [What Makes Radioligand Therapy IND Strategy Fundamentally Different?](https://blog.td2inc.com/what-makes-radioligand-therapy-ind-strategy-fundamentally-different)
- [Receptor Mediated Therapies in the Clinic: From Targeting to Impact](https://blog.td2inc.com/receptor-mediated-therapies-in-the-clinic)
- [A Translational Lens on Synergistic Cancer Therapy: Insights from Our Recent Case Study](https://blog.td2inc.com/a-translational-lens-on-synergistic-cancer-therapy-insights-from-our-recent-case-study)
- [Redesigning Preclinical Oncology: A Framework for Improving Clinical Translatability with AI, RECIST-Inspired Metrics, and Systems-Level Thinking](https://blog.td2inc.com/redesigning-preclinical-oncology)
[Regulatory](https://blog.td2inc.com/tag/regulatory)
[Regulatory](https://blog.td2inc.com/tag/regulatory)
### [What Makes Radioligand Therapy IND Strategy Fundamentally Different?](https://blog.td2inc.com/what-makes-radioligand-therapy-ind-strategy-fundamentally-different)
March 4, 2026
Your browser does not support the video tag.
[Read more +](https://blog.td2inc.com/what-makes-radioligand-therapy-ind-strategy-fundamentally-different)
[Regulatory](https://blog.td2inc.com/tag/regulatory)[Preclinical](https://blog.td2inc.com/tag/preclinical)
[Regulatory](https://blog.td2inc.com/tag/regulatory) [Preclinical](https://blog.td2inc.com/tag/preclinical)
### [Navigating the Preclinical-to-Clinical Transition for ADCs: Regulatory & Study Design Strategies](https://blog.td2inc.com/navigating-the-preclinical-to-clinical-transition-for-adcs)
March 12, 2025
Antibody-drug conjugates (ADCs) have emerged as a powerful class of targeted cancer therapeutics, combining the specificity of monoclonal antibodies ...
[Read more +](https://blog.td2inc.com/navigating-the-preclinical-to-clinical-transition-for-adcs)
[Regulatory](https://blog.td2inc.com/tag/regulatory)[Clinical](https://blog.td2inc.com/tag/clinical)
[Regulatory](https://blog.td2inc.com/tag/regulatory) [Clinical](https://blog.td2inc.com/tag/clinical)
### [The Cost of Delay: Quantifying the Financial Impact of Inefficient Clinical Trial Start-Up](https://blog.td2inc.com/quantifying-the-financial-impact-of-inefficient-clinical-trial-start-up)
February 5, 2025
Clinical trial start-up delays are not just operational hurdles—they can result in significant financial losses. In oncology trials, where timelines ...
[Read more +](https://blog.td2inc.com/quantifying-the-financial-impact-of-inefficient-clinical-trial-start-up)
[Regulatory](https://blog.td2inc.com/tag/regulatory)[Clinical](https://blog.td2inc.com/tag/clinical)
[Regulatory](https://blog.td2inc.com/tag/regulatory) [Clinical](https://blog.td2inc.com/tag/clinical)
### [Navigating the Complexities of Clinical Trial Start-Up](https://blog.td2inc.com/navigating-the-complexities-of-clinical-trial-start-up)
August 23, 2024
The Challenge: Overcoming Inefficiencies in Trial Start-Up The period between receiving the FDA’s “May Proceed” letter and activating trial sites for ...
[Read more +](https://blog.td2inc.com/navigating-the-complexities-of-clinical-trial-start-up)
### Get Started
## Contact Us Today!
If you’re looking for an expert team to guide your trial with efficiency in mind, we can help. As the creators of the Dynamic Trial, TD2 provides start-to-finish support with trial strategy, design and execution for faster go-to-market potential.
[Get Started Now](https://td2inc.com/contact-us/)
[](https://td2inc.com/)
Office
13208 E. Shea Blvd,
Suite 100
Scottsdale, AZ 85259
Phone
(602) 358-8300
Connect with us
-
-
© 2026 Translational Drug Development. All Rights Reserved. [Terms and Conditions](https://td2inc.com/terms-and-conditions) | [Privacy Policy](https://td2inc.com/privacy-policy)
```json
{
"@context" : "https://schema.org",
"@type" : "BlogPosting",
"author" : {
"@type" : "Person",
"name" : "TD2 Admin",
"url" : "https://blog.td2inc.com/author/td2-admin"
},
"dateModified" : "2024-05-13T10:54:08.099Z",
"datePublished" : "2018-09-18T16:21:00.000Z",
"headline" : "Oncology Drug Approval Process",
"mainEntityOfPage" : {
"@id" : "https://blog.td2inc.com/oncology-drug-approval-process",
"@type" : "WebPage"
},
"publisher" : {
"@type" : "Organization",
"logo" : {
"@type" : "ImageObject",
"url" : "https://blog.td2inc.com/hubfs/TD2-Oncology-01-2.png"
},
"name" : "Translational Drug Development"
}
}
```