The Pharma Data

DECEMBER 29, 2020

Proceeds will be used to fund LyGenesis’s Phase 2a clinical trial with a first patient in targeted for early 2021, as well as to push forward on their other cell therapies using lymph nodes as bioreactors to regrow functioning organs, including pancreas, kidney, and thymus regeneration. and Longevity Vision Fund.

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The Pharma Data

MAY 13, 2021

No searching, no trial and error and no risks of making my condition worse than it already was. I looked at a number of testimonials before trying Christian’s program. And that’s why Christian receives so many testimonials from grateful, happy people. I’d do it and then see what happened. Like me, they were wrong.

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Agency IQ

JUNE 29, 2023

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .” to include devices.

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The Pharma Data

MAY 13, 2021

In a major double-blind clinical trial published in the American College of Endocrinology…. Which has been proven in numerous clinical trials to: Rhodiola is a flowering plant that grows in the remote regions of the Arctic… And in a major randomized, double-blind, and placebo-controlled study published in the Journal Planta Medica….

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