Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 40

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 40
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The failure to comply with applicable U.S. requirements at any time during the product development process, approval process or after
approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to
approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of
letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of
government contracts, denial of the ability to import and export certain products, restitution, disgorgement of profits, or civil or
criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.

An applicant seeking approval to market and distribute
a new drug product in the United States must typically undertake the following:

●completion
                                            of preclinical laboratory tests, animal studies and formulation studies in compliance with
                                            the FDA’s good laboratory practice regulations;

    ●
    submission to the FDA of an IND, which must take effect before human
    clinical trials may begin;

    ●
    approval by an independent institutional review board representing
    each clinical site before each clinical trial may be initiated;

    ●
    performance of adequate and well-controlled human clinical trials in
    accordance with good clinical practices to establish the safety and efficacy of the proposed drug product for each indication;

    ●
    preparation and submission to the FDA of a 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.

19

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 vitro and animal studies to