Company: PTHS
Filing Date: 2025-09-16
Form Type: 8-K/A
Source: 0001753926-25-001500
Chunk: 19

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-09-16
Form: 8-K/A
Chunk 19
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 security laws, regulations, and other obligations are constantly evolving, may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to significant civil and/or criminal penalties and restrictions on data processing.

Government Regulation and Product Approval

Government authorities
in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the
research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion,
advertising, distribution, marketing and export and import of products such as those we are developing. A new drug must be approved
by the FDA through the new drug application (“NDA”) process before it may be legally marketed in the United States.

U.S. drug development process

In the United States,
the FDA regulates drugs under the federal Food, Drug, and Cosmetic Act (the “FDCA”) and its implementing regulations.
The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal, state and local statutes
and regulations require the expenditure of substantial time and financial resources. The process required by the FDA before a drug
may be marketed in the United States generally involves the following:

| • | completion of certain preclinical laboratory tests, animal studies and formulation studies in accordance with good laboratory practice (“GLP”) regulations and other applicable regulations; |

| • | submission to the FDA of an IND, which must become effective before human clinical trials may begin; |

| • | approval by an IRB, or ethics committee at each clinical site before each trial may be initiated; |

| • | performance of adequate and well-controlled human clinical trials in accordance with good clinical practices (“GCPs”) to evaluate the safety and efficacy of the product candidate for its intended use; |

| • | submission to the FDA of an NDA after completion of all pivotal trials; |

| • | satisfactory completion of an FDA advisory committee review, if applicable; |

| • | satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with cGMPs to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |

| • | satisfactory                                                                                                    
 completion of potential inspection of selected clinical investigation sites to assess compliance with GCPs; and |

| • | FDA                                                                                                                           
 review and approval of the NDA to permit commercial marketing of the product for particular indications for use in the United 
 States