Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 429

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 429
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animal or in vitrotesting) that suggest a significant risk for humans. The report must include any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator brochure. The sponsor must also notify the FDA of any unexpected fatal or life -threateningsuspected adverse reaction as soon as possible but in no case later than seven calendar days after the sponsor’s initial receipt of such information. It is possible that Phase 1, Phase 2, Phase 3 and other types of clinical trials may not be completed successfully, if at all. The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or if the drug or biologic has been associated with unexpected serious harm to patients. Concurrent with clinical trials, sponsors usually complete additional animal studies and also must provide additional information about the chemistry and physical characteristics of the drug or biologic as well as finalize a process for manufacturing the product candidate in commercial quantities in accordance with cGMP requirements. FDA Review Process Following completion of the clinical trials, data are analyzed to assess whether the investigational product is safe and effective for the proposed indicated use or uses. The results of preclinical studies and clinical trials are then submitted to the FDA as part of an NDA or BLA, along with proposed labeling, chemistry and manufacturing information to ensure product quality and other relevant data. The NDA or BLA is a request for approval to market the drug or biologic for one or more specified indications and must contain proof of safety and efficacy for a drug or safety, purity and potency for a biologic. The application may include both negative and ambiguous results of preclinical studies and clinical trials, as well as positive findings. Data may come from company -sponsoredclinical trials intended to test the safety and efficacy of a product’s use or from a number of alternative sources, including studies initiated by investigators. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational product to the satisfaction of FDA. FDA approval of an NDA or BLA must be obtained before a drug or biologic may be marketed in the United States. Under the Prescription Drug User Fee Act, or “ PDUFA,” as amended, each NDA