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BioSpace6d
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 ...
Fierce Pharma6d
‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view | ...
BioSpace6d
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 ...
Clinical Pain Advisor2d
FDA Publishes Full Texts of Response Letters to Drug Applications
The US FDA has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.
Cancer Therapy Advisor6d
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.
The Manila Times6d
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 ...
PharmTech6d
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.
FDA rejects Ultragenyx gene therapy over manufacturing concerns
While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...
Medpage Today on MSN9h
CRLs Are the Low-Hanging Fruit of FDA Transparency, Experts Say
For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...
Ophthalmology Times11h
FDA accepts for review Aldeyra Therapeutics’ resubmitted New Drug Application for reproxalap
The FDA accepted Aldeyra's resubmitted NDA for reproxalap after previous rejections due to efficacy concerns, despite no ...
Applied Clinical Trials Online6d
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...
Pharmaceutical Technology on MSN3d
Ultragenyx receives complete response letter for UX111 BLA
The FDA's request stems from observations made during recent inspections of Ultragenyx's manufacturing facilities.