Drug Target Review

APRIL 7, 2025

The parallel evolution of novel therapies, biomarker endpoints and regulatory evolution may signal a new paradigm for clinical drug development over the coming years. Silver Spring (MD): Food and Drug Administration (US); 2016-. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics.

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The Premier Consulting Blog

JUNE 18, 2023

A Modern Twist for the Gold Standard of Clinical Research The gold standard for clinical research intended for regulatory approval is the randomized controlled trial that compares an investigational drug candidate to either a placebo, active control, or standard of care (SoC).

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Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices.

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Agency IQ

FEBRUARY 2, 2024

But there are some potential hints, such as an upcoming Friends of Cancer Research event at which several of FDA’s top officials will be speaking on the “implementation of diversity plans.” FDA’s final regulation on this topic cleared White House review on January 5 , and is expected to be released imminently.

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