Agency IQ

NOVEMBER 3, 2023

This has allowed them instead to be developed and run primarily under oversight from other agencies – including the Centers for Disease Control and Prevention (CDC) and Center for Medicare and Medicaid Services (CMS) – under a policy known as the Clinical Laboratory Improvement Amendments (CLIA). A trial run: The Covid-19 EUA transition.

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Agency IQ

AUGUST 18, 2023

The subgroup continues to work through technical aspects of certificates, clinical trial and performance study applications, vigilance and trending reports and market surveillance. We’ve seen what’s been going on with the MDR, but the main concern we’ve heard of IVDR is the performance study application process is affecting drug trials.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Codon

OCTOBER 6, 2024

Results such as these have been so encouraging that in September of last year, the FDA began to review the idea of moving to human trials. Indeed, the stakes in the first real-world use of artificial wombs may be higher than in almost any clinical trial imaginable. ” Others have much more ambitious plans for the next five years.

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The Pharma Data

DECEMBER 30, 2020

This week, Bloomberg reported companies agreed to slash the prices of 119 new therapies that treat a range of illnesses, including pulmonary disease, lupus, diabetes and cancer. billion by 2027. Belarus was also the first foreign country to begin clinical trials of Sputnik V. Most Read Today. Source link.

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Agency IQ

FEBRUARY 21, 2024

In sum, the aim of the organization and its stakeholders is to develop an online environment to house everything from clinical trial data to marketing applications, to product labeling, manufacturing changes, and more. The top request to TGA from stakeholders was for increased international harmonization and cooperation.

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The Pharma Data

MAY 4, 2021

Rare Disease. RE47,739 for Ibrance by more than four years until March 2027. Vaccine effectiveness in the study will be inferred through immunobridging to the 16 to 25 year-old population in the pivotal Phase 3 trial. The vaccine was 100% effective against severe disease as defined by the U.S. Internal Medicine.

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Agency IQ

FEBRUARY 2, 2024

BY LAURA DIANGELO, MPH | JAN 30, 2024 10:25 AM CST Diagnostic regulation: A quick overview Diagnostics products are those intended to identify, signal or detect a specific health condition, infection or disease, or monitor a person’s health or health status. In-house tests (similar to LDTs in the U.S.,

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Agency IQ

JULY 28, 2023

September 2023 Legislative deadlines in Q3 Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

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