Therapeutic Solutions International Inc (TSOI)

[BigBadWolf]

Already attempting to spin, Why? https://www.federalregister.gov/documents/2022/09/14/2022-19737/annual-summary-reporting-requirements-under-the-right-to-try-act

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to specify the deadline and content for submission of an annual summary of investigational drugs supplied under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act) and the uses for which the investigational drugs were supplied. This final rule implements a provision in the Right to Try Act that requires sponsors and manufacturers who provide an “eligible investigational drug” under the provisions of the Right to Try Act to submit to FDA an annual summary of such use, and directs FDA to specify by regulation the deadline of submission.

V. Effective/Compliance Date(s)

This final rule becomes effective 60 days after publication in the

Federal Register

. Any manufacturer or sponsor who provides an eligible investigational drug for use by an eligible patient in accordance with the Right to Try Act must include in their first annual summary submitted under this section any use from the time of enactment of the Right to Try Act, May 30, 2018, through December 31, 2022. The first annual summary submitted under the Right to Try Act will be required to be submitted March 31, 2023.

Thus, for a manufacturer or sponsor of an eligible investigational drug that has supplied an eligible patient with an eligible investigational drug under section 561B of the FD&C Act between the period from enactment of section 561B (May 30, 2018) and December 31, 2022, the manufacturer or sponsor shall submit to FDA a first annual summary covering that period no later than March 31, 2023. After this annual report, the manufacturer or sponsor must submit a report that covers every January 1 through December 31 annual period by no later than March of the following year, for every year in which the manufacturer or sponsor has supplied a drug under the Right to Try Act. Therefore, a report submitted in March 2024, would cover the period January 1, 2023, through December 31, 2023.

Hooky hooky my arse