Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 141

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 141
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 new drug application; |

| ● | review of the product by                                       
 an FDA advisory committee, where appropriate or if applicable; |

| ● | satisfactory completion                                                                                                              
 of one or more FDA inspections of the manufacturing facility or facilities at which the product, or components thereof, are produced 
 to assess compliance with cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the    
 product’s identity, strength, quality and purity;                                                                                    |

| ● | satisfactory completion                                                                                      
 of FDA audits of clinical trial sites to assure compliance with GCPs and the integrity of the clinical data; |

| ● | payment of user fees and              
 securing FDA approval of the NDA; and |

| ● | compliance with any post-approval                                                                                
 requirements, including Risk Evaluation and Mitigation Strategies and post-approval studies required by the FDA. |

Preclinical Studies Preclinical studies include laboratory evaluation of the purity and stability of the manufactured drug substance or active pharmaceutical ingredient and the formulated drug or drug product, as well as in vitroand animal studies to assess the safety and activity of the drug for initial testing in humans and to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations. The results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and plans for clinical trials, among other things, are submitted to the FDA as part of an IND. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after the IND is submitted. 88 Companies usually must complete some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, and must also develop additional information about the chemistry and physical characteristics of the investigational product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. The IND and IRB Processes An IND is an exemption from the FDCA that allows an unapproved drug to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization to administer an investigational drug to humans