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FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
BioSpace1d
FDA Publishes Cache of Complete Response Letters in Bid for ‘Radical Transparency’
The trove of more than 200 letters is part of a pledge of transparency from the agency, with the intention to increase public ...
The Manila Times1d
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are ...
Capricor: Maintaining Hold Rating In Light Of Deramiocel Complete Response Letter
Capricor Therapeutics is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...
BioSpace1d
FDA Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
pharmaphorum1d
Just how radical is the FDA's complete response letter move?
The FDA has called a plan to publish certain complete response letters (CRLs) for medicines it has rejected after an initial ...
PharmTech1d
FDA Publishes More Than 200 Complete Response Letters
FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.
Cancer Therapy Advisor1d
FDA Publishes Complete Response Letters for Drug Applications
The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.
Fierce Biotech2d
FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
FDA publishes more than 200 rejection letters in a bid to improve transparency
The U.S. FDA publishes over 200 complete response letters to enhance transparency within the agency. Read more here.
Morningstar2d
FDA Publishing Complete Response Letters to Boost Transparency
The FDA issues complete response letters when it determines that it can't approve an application in its current form, mostly due to safety and efficacy concerns, manufacturing deficiencies or ...