News / Press Release

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 goes to the sponsors, also.

About Translational Drug Development (TD2)

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

About TD2

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

Contact
Tara Franks
602-358-8322
Get free tips, tools and resources by subscribing to the TD2 Newsletter: