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Explaining the FDA’s Drug Review Process

Every prescription drug in the United States must pass through an extensive review process by the Food and Drug Administration (FDA) before it can be marketed to consumers. This rigorous evaluation is designed to ensure that medications are safe, effective, and properly labeled. Despite these safeguards, however, some defective drugs still make it to market and cause harm to patients. The Shapiro Legal Group, PLLC has an experienced Ozempic injury attorney ready to answer your questions and fight for your legal rights.

Why Does the FDA Have an Extensive Drug Review Process?

Defective drugs can have devastating consequences for patients, causing serious injuries, chronic health conditions, and even death. The FDA’s review process aims to minimize these risks by thoroughly evaluating the safety and efficacy of new medications before they are approved for widespread use. This process involves multiple stages of testing and analysis to ensure that the benefits of a drug outweigh its potential risks.

The FDA’s oversight helps protect public health and maintain confidence in the medical system. Without this rigorous review, pharmaceutical companies could market drugs that are ineffective, dangerous, or improperly labeled.

The Different Stages of Drug Development and Review

The FDA’s drug review process involves several distinct stages, each designed to evaluate a specific aspect of the medication’s safety and effectiveness. These stages include:

  • Preclinical Testing: Before a drug can be tested in humans, it must undergo extensive testing in laboratory animals to assess its safety and biological activity.
  • Investigational New Drug Application (IND): The drug sponsor submits an IND to the FDA, outlining their plan for human clinical trials. The FDA reviews the IND to ensure that the proposed trials are reasonably safe and scientifically sound.
  • Clinical Trials: If the IND is approved, the drug sponsor can begin human clinical trials. These trials are divided into three phases. Phase 1 studies, conducted in healthy volunteers, assess the drug’s safety, side effects, and how it is metabolized and excreted. Phase 2 studies evaluate the drug’s effectiveness in people with the targeted disease or condition while continuing to monitor safety and short-term side effects. Finally, large-scale Phase 3 studies gather more information about the drug’s safety and effectiveness in different populations, dosages, and in combination with other drugs.
  • New Drug Application (NDA): After completing the clinical trials, the drug sponsor submits an NDA to the FDA, requesting approval to market the drug in the United States. The NDA includes all animal and human data, analyses of the data, and information about the drug’s manufacturing process.
  • FDA Review: The FDA has 60 days to decide whether to file the NDA for review. If filed, an FDA review team evaluates the sponsor’s research on the drug’s safety and effectiveness. The FDA also reviews the proposed labeling and inspects the manufacturing facilities.
  • FDA Decision: The FDA will either approve the NDA or issue a complete response letter, detailing the deficiencies that must be addressed before the drug can be approved.
  • Post-Market Studies: After a drug is approved, the FDA may require or request post-market studies to gather additional information about the drug’s safety, efficacy, or optimal use.

Have You Been Affected by a Dangerous and Defective Drug?

The FDA has strict regulations when bringing a drug to market, but dangerous and defective medications can slip through the cracks. If you have been affected by a defective drug, the attorneys at Shapiro Legal Group, PLLC can help you pursue legal action against the responsible party. Contact us at (800) 220-0984 for a free, no-obligation consultation and begin your journey to justice today.