Company: OSRH
Filing Date: 2025-05-28
Form Type: S-1
Source: 0001213900-25-048346
Chunk: 13

Company: OSR Holdings, Inc.
Filing Date: 2025-05-28
Form: S-1
Chunk 13
---
NDA) review.                                                                        |

Regulatory Steps New Drug Application A New Drug Application (NDA) tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied. A drug developer must include everything about a drug — from preclinical data to Phase 3 trial data — in an NDA. Developers must include reports on all studies, data, and analyses. Along with clinical results, developers must include proposed labeling, safety updates, drug abuse information, patent information, any data from studies that may have been conducted in other countries, institutional review board compliance information and directions for use

5

NDA Review Once each authority such as FDA or EMA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug. The process includes the following:

| ● | Each member of the review team conducts a full review of his or her section of the application. For example, the medical officer         
 and the statistician review clinical data, while a pharmacologist reviews the data from animal studies. Within each technical discipline 
 represented on the team, there is also a supervisory review.                                                                             |

| ● | FDA or EMA inspectors travel to clinical study sites to conduct a routine inspection. The Agency looks for evidence of fabrication, 
 manipulation, or withholding of data.                                                                                               |

| ● | The project manager assembles all individual reviews and other                                                       
 documents, such as the inspection report, into an “action package.” This document becomes the record for NDA review. 
 The review team issues a recommendation, and a senior official makes a decision.                                     |

NDA Approval In cases where FDA or EMA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information. This is referred to as “labeling.” Labeling accurately and objectively describes the basis for approval and how best to use the drug. FDA Advisory Committees Often, the NDA contains sufficient data for FDA or EMA to determine the safety and effectiveness of a drug. Sometimes, though, questions arise that require additional consideration. In these cases, FDA or EMA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments