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A Final LDT Rule in April!? Will FDA be prepared?

The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

FDA

FDA Research Laboratories Documentation

Pharmaceutical microbiology: key developments 2022

European Pharmaceutical Review

JANUARY 16, 2023

He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.

Vaccines

Vaccines FDA Research Laboratories Documentation

Pharmacy Technician Pulse

A Final LDT Rule in April!? Will FDA be prepared?

Pharmaceutical microbiology: key developments 2022

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