The drug approval process of the US Food and Drug Administration (FDA) mainly includes the following stages:
Preclinical Research
According to regulatory documents such as the Good Laboratory Practice (GLP) on the official website of the FDA, the standards and norms for preclinical research are defined. Preclinical research is the first step in the drug approval process. Pharmaceutical companies need to conduct extensive preclinical research, including pharmacological and toxicological studies, mainly in laboratories or animal models, to evaluate the safety and effectiveness of the drug, preliminarily explore the mechanism of action and metabolic pathways of the drug, and provide data support for subsequent human clinical trials.
Submission of Investigational New Drug Application (IND)
According to the FDA's "Guidance for Industry: Investigational New Drug Application", which details the submission requirements and process of IND. When the preclinical research data indicates that the drug may be safe and effective, the pharmaceutical company will submit an Investigational New Drug Application (IND) to the FDA. The IND contains preclinical research data, manufacturing information, clinical trial protocols, etc., aiming to prove to the FDA that it is safe to conduct trials on humans and that the clinical protocol design for the research purpose is reasonable and effective.
Clinical Trials
Phase I Clinical Trial: Conducted in a small number of healthy volunteers, mainly to test the safety, tolerability, and preliminary pharmacokinetics and pharmacodynamics of the drug in humans, determine the maximum tolerated dose and optimal dosing regimen of the drug, and provide dose and safety references for subsequent clinical trials.
Phase II Clinical Trial: Conducted in patients with the target disease, focusing on the effectiveness and side effects of the drug, preliminarily evaluating the therapeutic effect of the drug on the disease, and further observing the safety of the drug to provide a basis for the design and implementation of Phase III clinical trials.
Phase III Clinical Trial: Conducted in a larger patient population to further confirm the effectiveness of the drug, more comprehensively monitor side effects, and compare with existing treatment methods to evaluate the advantages and risks of the drug. The results of this stage of the trial are crucial for whether the drug can be approved for marketing.
Submission of New Drug Application (NDA) or Biologics License Application (BLA)
NDA: If the clinical trial results are positive, the pharmaceutical company will submit a New Drug Application (NDA). The NDA includes detailed information such as clinical trial data, drug ingredients and dosage forms, production processes, sample labels, and suggestions for drug use to prove the safety, effectiveness, and quality controllability of the drug.
BLA: If the clinical trial results are positive, the pharmaceutical company will submit a Biologics License Application (BLA). For biologics such as vaccines, blood products, and cell therapy products, the submitted materials include specific information materials on the production process, chemistry, pharmacology, clinical pharmacology, and medical impact of the biologics to support the review and final approval of the biologics for marketing in the United States.
FDA Review
The FDA reviews the submitted NDA or BLA. This process includes careful analysis and evaluation of the data provided in the application materials, as well as inspection of the production facilities to ensure that the drug production process complies with regulatory requirements, the data is reliable, the drug quality is controllable, and the risk-benefit balance is maintained.
Approval Decision
If the FDA believes that the drug meets the requirements after review, it will approve the drug for marketing and issue the corresponding license. Conversely, if problems or insufficient data are found, the FDA may require the pharmaceutical company to supplement information or conduct further research, or even reject the application.
Post-market Surveillance
After the drug is marketed, the FDA will continue to conduct post-market surveillance, including monitoring the safety and effectiveness of the drug, as well as the production and distribution activities of the pharmaceutical company. Pharmaceutical companies are required to submit pharmacovigilance reports regularly to monitor adverse reactions and other safety issues of the drug in the widely used population so that measures can be taken in a timely manner to protect public health.
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