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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Cancer Therapies02:49

Cancer Therapies

Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
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Cancer Therapies02:49

Cancer Therapies

Cancer therapies are various modes of treatment, such as surgery, radiation therapy, and chemotherapy that are administered to cancer patients.
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Drug Discovery: Overview01:26

Drug Discovery: Overview

Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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The pharmacokinetic phase...

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A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines
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Published on: March 4, 2017

Oncology drug review process.

Ann T Farrell1, Richard Pazdur

  • 1Division of Oncology Drug Products, Office of Drug Evaluation I, Center for Drug Evaluation and Research, United States Food and Drug Administration, Rockville, Maryland 20857, USA. farrella@cder.fda.gov

Journal of the National Comprehensive Cancer Network : JNCCN
|September 22, 2009
PubMed
Summary
This summary is machine-generated.

The U.S. Food and Drug Administration (FDA) streamlines cancer drug approval through regular and accelerated pathways. Priority review accelerates the assessment of promising new oncology therapies.

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Area of Science:

  • Oncology Drug Development
  • Regulatory Science
  • Clinical Trial Endpoints

Background:

  • The U.S. Food and Drug Administration (FDA) plays a crucial role in advancing treatments for cancer and other severe diseases.
  • Understanding the regulatory pathways is essential for drug developers and healthcare professionals.

Purpose of the Study:

  • To outline the New Drug Application (NDA) process for oncology drugs.
  • To describe endpoints used in cancer clinical trials.
  • To highlight FDA initiatives for expedited drug review.

Main Methods:

  • Description of the FDA's New Drug Application (NDA) process.
  • Explanation of regular vs. accelerated marketing approval criteria.
  • Discussion of priority vs. standard application review timelines.

Main Results:

  • Regular approval requires demonstrated clinical benefit (e.g., improved survival, quality of life).
  • Accelerated approval uses surrogate endpoints predicting clinical benefit for serious/life-threatening illnesses.
  • Priority review shortens FDA assessment to 6 months for significant therapeutic improvements, versus 10 months for standard review.

Conclusions:

  • The FDA employs distinct pathways to facilitate the development and review of oncology drugs.
  • Endpoint selection is critical for demonstrating drug efficacy and safety.
  • Expedited review programs aim to bring meaningful therapies to patients faster.