Company: OSRH
Filing Date: 2025-01-24
Form Type: S-4/A
Source: 0001213900-25-006139
Chunk: 427

Company: OSR Holdings, Inc.
Filing Date: 2025-01-24
Form: S-4/A
Chunk 427
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 an IND application may prompt FDA to, among other things, scrutinize existing INDs or marketed products and could generate requests for information or clinical holds on other product candidates or programs. Clinical Trials The clinical stage of development involves the administration of the investigational product to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCP requirements, which include the requirement that all research participants provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, participant inclusion and exclusion criteria, and the parameters to be used to monitor safety and assess efficacy. Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND. Furthermore, each clinical trial must be reviewed and approved by a centralized or independent IRB for each institution at which the clinical trial will be conducted to ensure that the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves participant -facingmaterials, including the informed consent form that must be provided to each clinical trial participant or their legal representative, and must monitor the clinical trial until completed. There also are requirements governing the reporting of ongoing clinical trials and completed clinical trial results to public registries. Information about certain clinical trials, including clinical trial results, must be submitted within specific timeframes for publication on the www.clinicaltrials.govwebsite. A sponsor who wishes to conduct a clinical trial outside of the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. If a foreign clinical trial is not conducted under an IND, the sponsor may submit data from the clinical trial to the FDA in support of an NDA or BLA. The FDA will accept a well -designedand well -conductedforeign clinical trial not conducted under an IND if the study was conducted in accordance with GCP requirements, including review and approval by an independent ethics committee and informed consent from subjects, and the FDA is able to validate the data through an onsite inspection if deemed necessary. Clinical trials, generally, are conducted in three sequential phases, known as Phase 1, Phase 2 and Phase 3, and may overlap. • Phase 1clinical trials generally involve a small number of healthy volunteers or disease -affectedpatients who are initially exposed to a single dose and then multiple doses of the product candidate. The primary purpose of