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US FDA’s Non-Guidance On Osteoarthritis Drugs: Starting Over On Structural Claims

 
• By Michael McCaughan

Agency essentially ruling out use of structural endpoints to support disease progression claims for osteoarthritis drugs in new draft guidance.

The US FDA’s new draft guidance on structural endpoints for osteoarthritis drug development is an unusual example of the agency’s “just-say-it” approach to guidance writing.

The text of the guidance is just over two pages – and shorter than the three pages of cover material...

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
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The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.

MHRA Backs Bacteriophage Innovation To Fight Antimicrobial Resistance

 
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